Protection Gloves Sdn. Bhd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Protection Gloves Sdn. Bhd.” (first 1995, latest 2001), across 1 product code 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 | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Protection Gloves Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011231 | CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN | LYY | 2001-06-13 | 51 |
| K010854 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) | LYY | 2001-06-13 | 83 |
| K000668 | POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA | LYY | 2000-04-28 | 60 |
| K000667 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM | LYY | 2000-04-28 | 60 |
| K945164 | MULTIPLE | LYY | 1995-02-03 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Protection Gloves Sdn. Bhd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Protection Gloves Sdn. Bhd.?
FDA lists 5 510(k) clearances under the applicant name “Protection Gloves Sdn. Bhd.” (first 1995, latest 2001), across 1 product code 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 Protection Gloves Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Protection Gloves Sdn. Bhd. is 60 days.
Which FDA product codes appear under Protection Gloves Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5).
Next steps
- See all 5 Protection Gloves Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Protection Gloves Sdn. Bhd.'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.