SURGICAL GOWN, SMS (K121152): indications, design and recorded evidence
The acquired K121152 file contains product-specific indications and users, recorded comparison and differences, performance evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-08. Source versions and topic-specific limits are listed below.
Computed exact-code research
This decision beside its recorded product-code cohort
The 2021–2025 complete-year cohort contains 62 selected decisions under primary code FYA. 62 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
Calendar elapsed days: lower quartile 119.0, median 170.0, upper quartile 269.5. These are recorded calendar differences, not active FDA review time.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Calculation, selection and source versions
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01,
are non-sterile, single use surgical gowns intended to protect surgical
patients and operating room personnel from the transfer of microorganisms,
body fluids, and particulate material.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
The following table shows similarities and differences between the predicate identified in
Section 5 of this summary. There are no significant differences between the Jiangsu
Guangda's Gowns, Model Number GD-SG-O1, and their respective predicate products.
Compare with your product: The summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
The information in the Premarket Notification on safety and efficiency supports a finding
of substantially equivalence to devices already in commercial distribution. Equivalence is
demonstrated through intended use, material, design and testing methods.
Compare with your product: The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Extraction selection and limits
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
Historical references beside dated FDA recognition metadata
Read each mention in the linked original summary, including statements that testing was not performed. Recognition metadata does not determine your testing needs, chosen edition or transition eligibility.
Reference in this historical summary
Designation in the acquired FDA export
Recognition / entry date
Recorded transition-expiration date
Sources
ISO 11135 7. Intended Use
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ANSI AAMI ISO 11135:2014/A1:2018 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E Single batch release
Prepare for your provider: the proposed protocol/report edition, its justification for your device and the complete current FDA recognition sheet. In particular, inspect exclusions for partial recognition. An edition difference does not automatically make the historical evidence unusable.
Identifier-matching method and selection limits
Match explicit ISO/IEC identifiers in selected preserved summary excerpts to the acquired, count-reconciled FDA metadata export. Preserve the historical edition mention, current snapshot designations, entry dates, recognition extent and any recorded transition-expiration date as separate facts. No title-similarity, edition-equivalence, test-mandate or transition-eligibility inference. At most twenty matched occurrences and thirty metadata rows per reference; wide matches are held for separate review.
1 of 1 matched reference occurrences shown.
Known facts and deciding inputs
Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.
Dated official record fact; not proof of current commercial availability or applicability to another device.
Prepare a differences and evidence worksheet
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Indications and users — what differs in our product?
Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.
Recorded comparison and differences — what differs in our product?
The summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
Useful evidence: Feature-by-feature differences and the underlying cited documents; no automated predicate selection.
Performance evidence actually described — what differs in our product?
The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Useful evidence: The cited narrative and full tables, underlying protocols/results and a reviewed comparison with the proposed product.
Which edition and recognition limits would our provider rely on?
Compare each historical reference below with the dated FDA metadata. Ask the specialist to justify the applicable scope and selected edition, read the complete supplementary sheet for partial-recognition exclusions, and investigate any recorded transition conditions. A difference in editions does not automatically make the earlier study unusable.
Useful evidence: Proposed protocol/report edition, dated FDA recognition sheet with scope/exclusions, and a documented edition/transition rationale for the actual device.
Work packages and dependencies
Conditional: Indication, design and evidence-gap comparison — Compare the named summary and underlying official records with the proposed product; document the differences, applicable route questions and evidence gaps before agreeing submission or testing deliverables.
Questions for providers
Which specific differences from the cited indication, design and operating principle change our proposed evidence work?
What source limitations or missing protocols/results must be resolved before treating this recorded evidence as comparable?
Which additional records and current guidance support the proposed route, and how will the comparison avoid assuming predicate suitability?
Which exact standard edition and FDA recognition scope would your proposed work use, and how would you justify differences from the historical references shown?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
