Ansell Perry: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Ansell Perry” (first 1997, latest 2001), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 15 | 15 |
| LYY | Latex Patient Examination Glove | 5 | 5 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (22)
Most recent Ansell Perry 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003895 | X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 | KGO | 2001-01-17 | 30 |
| K002192 | DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 | KGO | 2000-07-27 | 7 |
| K001239 | ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | 2000-05-15 | 27 |
| K000165 | NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | 2000-03-10 | 51 |
| K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | 2000-02-16 | 16 |
| K993857 | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR | KGO | 2000-01-31 | 77 |
| K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | KGO | 1999-10-29 | 58 |
| K992156 | SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES | LYZ | 1999-10-27 | 124 |
| K992768 | NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | LZA | 1999-10-13 | 57 |
| K984559 | ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | 1999-02-26 | 65 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ansell Perry.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ansell Healthcare Products, LLC (36 510(k)s)
- Ansell, Inc. (30 510(k)s)
- Ansell Intl. (4 510(k)s)
- Ansell Healthcare, Inc. (3 510(k)s)
- Ansell Edmont Industrial, Inc. (2 510(k)s)
- Ansell Pacific, Inc. (2 510(k)s)
- Ansell Heathcare Products, LLC (1 510(k)s)
- Ansell Malaysia Sdn Bhd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ansell Perry?
FDA lists 22 510(k) clearances under the applicant name “Ansell Perry” (first 1997, latest 2001), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ansell Perry?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ansell Perry is 56 days.
Which FDA product codes appear under Ansell Perry?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 15); LYY (Latex Patient Examination Glove, 5); LYZ (Vinyl Patient Examination Glove, 1).
Next steps
- See all 22 Ansell Perry clearances with predicates and recalls
- Run predicate analysis for product code KGO, Ansell Perry's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.