Perusahaan Pelindung Getah (M) Sdn Bhd
Sembilan Darul Khusus Malaysia, ML
Perusahaan Pelindung Getah (M) Sdn Bhd appears in FDA device records in Sembilan Darul Khusus Malaysia, ML. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Perusahaan Pelindung Getah (M) Sdn Bhd between 1989 and 2008. The busiest year on record is 2000, with 4. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1994 | 1 |
| 2000 | 4 |
| 2003 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072300 | POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K032201 | RUBBERCARE POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K002111 | RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI | LYY | Substantially Equivalent | |
| K002112 | RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE | LYY | Substantially Equivalent | |
| K002114 | RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER | LYY | Substantially Equivalent | |
| K994201 | RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K933759 | RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED | LYY | Substantially Equivalent | |
| K891123 | RUBBERCARE PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain