Perusahaan Getah Asas Sdn. Bhd.
JERAM Selangor, MY
PERUSAHAAN GETAH ASAS SDN. BHD. appears in FDA device records in JERAM Selangor, MY. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Perusahaan Getah Asas Sdn. Bhd. between 1989 and 2010. The busiest year on record is 2003, with 10. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1995 | 1 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 10 |
| 2004 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | |
| K042805 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE | LZC | Substantially Equivalent | |
| K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | Substantially Equivalent | |
| K031768 | BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED | LZA | Substantially Equivalent | |
| K031625 | POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED | LZA | Substantially Equivalent | |
| K031591 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED | LZA | Substantially Equivalent | |
| K031414 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE | LYY | Substantially Equivalent | |
| K031021 | CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K030333 | LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM | LYY | Substantially Equivalent | |
| K030331 | ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K030335 | ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED | LZA | Substantially Equivalent | |
| K024184 | POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED | LZA | Substantially Equivalent | |
| K023262 | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) | LYY | Substantially Equivalent | |
| K022701 | POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E | LYY | Substantially Equivalent | |
| K022601 | POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) | LYY | Substantially Equivalent | |
| K011271 | POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED | LYY | Substantially Equivalent | |
| K010719 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR | LZA | Substantially Equivalent | |
| K003737 | POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) | LYY | Substantially Equivalent | |
| K002314 | LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR | LYY | Substantially Equivalent | |
| K001529 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA | LYY | Substantially Equivalent | |
| K991511 | POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) | LZA | Substantially Equivalent | |
| K984605 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) | LZA | Substantially Equivalent | |
| K984356 | NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) | LZA | Substantially Equivalent | |
| K983729 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K982807 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K982806 | CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K982440 | NITRILE PATIENT EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K980916 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K954365 | POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K891640 | PATIENT EXAMINATION GLOVES (LATEX)(POWDERED) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004553390 | 3004553390 | PERUSAHAAN GETAH ASAS SDN. BHD. | LOT 1365, BATU 17, JERAM Selangor 45800 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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