Perusahaan Pelindung Getah (M) Sdn Bhd: FDA clearances and approvals
Perusahaan Pelindung Getah (M) Sdn Bhd has 8 FDA 510(k) clearances (first 1989, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time: 71 days.
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 | 8 | 8 |
Review panels
- General Hospital (8)
Most recent Perusahaan Pelindung Getah (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072300 | POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM | LYY | 2008-05-16 | 273 |
| K032201 | RUBBERCARE POWDERED LATEX EXAMINATION GLOVES | LYY | 2003-10-10 | 84 |
| K002111 | RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI | LYY | 2000-09-08 | 58 |
| K002112 | RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE | LYY | 2000-08-14 | 33 |
| K002114 | RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER | LYY | 2000-08-11 | 30 |
| K994201 | RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-02-07 | 56 |
| K933759 | RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED | LYY | 1994-03-21 | 243 |
| K891123 | RUBBERCARE PATIENT EXAMINATION GLOVE | LYY | 1989-07-14 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Perusahaan Pelindung Getah (M) Sdn Bhd.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Perusahaan Pelindung Getah (M) Sdn Bhd have?
Perusahaan Pelindung Getah (M) Sdn Bhd has 8 FDA 510(k) clearances (first 1989, latest 2008), across 1 product code in 1 review panel.
How long does FDA take to clear Perusahaan Pelindung Getah (M) Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Perusahaan Pelindung Getah (M) Sdn Bhd's cleared 510(k)s is 71 days.
What devices does Perusahaan Pelindung Getah (M) Sdn Bhd make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 8).
Has Perusahaan Pelindung Getah (M) Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Perusahaan Pelindung Getah (M) Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 8 Perusahaan Pelindung Getah (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Perusahaan Pelindung Getah (M) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.