Hygenix (K232797): indications, design and recorded evidence
The acquired K232797 file contains product-specific indications and users, design and operating principle, non-clinical 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 2026-10-07. 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 352 selected decisions under primary code FXX. 352 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
Calendar elapsed days: lower quartile 91.0, median 149.5, upper quartile 227.8. 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.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
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; 1 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.
The Hygenix is intended to be worn to protect both the patient and health care personnel from 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 Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of
spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
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 physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
20. Fluid resistance Pass at 160 mmHg Pass at 160 mmHg Same
21. Flammability Class 1 Class 1 Same
22. Particulate Filtration ≥ 98% ≥ 98% Same
Efficiency (PFE)
23. Bacterial Filtration ≥ 98% ≥ 98% Same
Efficiency (BFE)
24.
Compare with your product: Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
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: {}.
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.
Design and operating principle — what differs in our product?
Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Useful evidence: Design description, materials/components, accessory list and a differences matrix.
Non-clinical evidence actually described — what differs in our product?
Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Useful evidence: Existing protocols/results and design-specific evidence gaps, with standard editions and scope reviewed separately.
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?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
