Wrp Specialty Products Sdn. Bhd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Wrp Specialty Products Sdn. Bhd.” (first 1999, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 | 12 | 12 |
| KGO | Surgeon'S Gloves | 3 | 3 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (18)
Most recent Wrp Specialty Products Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032016 | DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT | LYY | 2004-05-11 | 316 |
| K022808 | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) | LYY | 2002-10-03 | 41 |
| K021561 | DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O | LYY | 2002-06-11 | 29 |
| K021536 | DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR | LYY | 2002-06-10 | 31 |
| K021396 | DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | 2002-05-16 | 14 |
| K014288 | DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS | KGO | 2002-02-13 | 47 |
| K013942 | POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) | LYY | 2001-12-31 | 32 |
| K012876 | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2001-10-01 | 35 |
| K003309 | DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE | LYY | 2000-11-22 | 30 |
| K003307 | DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W | LYY | 2000-11-22 | 30 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wrp Specialty Products 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 Wrp Specialty Products Sdn. Bhd.?
FDA lists 18 510(k) clearances under the applicant name “Wrp Specialty Products Sdn. Bhd.” (first 1999, latest 2004), across 3 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 Wrp Specialty Products Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wrp Specialty Products Sdn. Bhd. is 34 days.
Which FDA product codes appear under Wrp Specialty Products Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 12); KGO (Surgeon'S Gloves, 3); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 18 Wrp Specialty Products Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Wrp Specialty Products 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.