Wrp Asia Pacific Sdn. Bhd.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Wrp Asia Pacific Sdn. Bhd.” (first 1999, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 206 days, against 118 days for all cleared 510(k)s in the same product codes. 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 | 1 | 127 |
| 2014 | 1 | 294 |
| 2015 | 1 | 199 |
| 2016 | 1 | 150 |
| 2017 | 1 | 206 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 116 |
| 2021 | 1 | 252 |
| 2022 | 3 | 393 |
| 2023 | 2 | 135 |
| 2024 | 1 | 259 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wrp Asia Pacific Sdn. Bhd. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 20 | 20 |
| LZA | Polymer Patient Examination Glove | 15 | 15 |
| LYY | Latex Patient Examination Glove | 6 | 6 |
| LZC | Medical Glove, Specialty | 5 | 5 |
Review panels
- General Hospital (46)
Most recent Wrp Asia Pacific Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | KGO | 2024-03-28 | 259 |
| K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | LZA | 2023-11-17 | 87 |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | KGO | 2023-08-31 | 183 |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | KGO | 2022-10-22 | 102 |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | LYY | 2022-08-22 | 455 |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | LZA | 2022-03-04 | 393 |
| K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | KGO | 2021-06-11 | 252 |
| K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | LZA | 2020-01-17 | 116 |
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | KGO | 2017-01-23 | 206 |
| K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2016-10-20 | 150 |
36 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-05-07.
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 Asia Pacific Sdn. Bhd.?
FDA lists 46 510(k) clearances under the applicant name “Wrp Asia Pacific Sdn. Bhd.” (first 1999, latest 2024), 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 Wrp Asia Pacific Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wrp Asia Pacific Sdn. Bhd. is 84 days. Since 2017: 206 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wrp Asia Pacific Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 20); LZA (Polymer Patient Examination Glove, 15); LYY (Latex Patient Examination Glove, 6).
Next steps
- See all 46 Wrp Asia Pacific Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Wrp Asia Pacific 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.