Safeskin Corp.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Safeskin Corp.” (first 1988, latest 2000), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 9 | 9 |
| KGO | Surgeon'S Gloves | 7 | 7 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| FMC | Patient Examination Glove | 2 | 2 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (24)
Most recent Safeskin Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993117 | SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG | LYY | 2000-03-02 | 164 |
| K994081 | SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES | KGO | 2000-01-18 | 46 |
| K992830 | SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE | LZA | 1999-10-27 | 65 |
| K992210 | SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES | LZA | 1999-09-10 | 71 |
| K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | LZC | 1999-08-30 | 66 |
| K992062 | SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES | LZA | 1999-08-25 | 68 |
| K991951 | SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) | LYZ | 1999-07-26 | 46 |
| K991317 | POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | KGO | 1999-05-21 | 32 |
| K970899 | SAFESKIN POWDERED EXAMINATION GLOVE | LYY | 1997-05-06 | 56 |
| K962139 | SAFESKIN | LZA | 1996-12-19 | 199 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Safeskin Corp..
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.
- Safeskin Retailing (Hk) Limited (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Safeskin Corp.?
FDA lists 24 510(k) clearances under the applicant name “Safeskin Corp.” (first 1988, latest 2000), across 6 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 Safeskin Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Safeskin Corp. is 60 days.
Which FDA product codes appear under Safeskin Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 9); KGO (Surgeon'S Gloves, 7); LZA (Polymer Patient Examination Glove, 4).
Next steps
- See all 24 Safeskin Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Safeskin Corp.'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.