Top Glove Sdn. Bhd.
KLANG Selangor, MY
TOP GLOVE SDN. BHD. appears in FDA device records in KLANG Selangor, MY. FDA records list 17 510(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 17 510(k) clearances for Top Glove Sdn. Bhd. between 1991 and 2020. The busiest year on record is 1999, with 5. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 1 |
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | LZA | Substantially Equivalent | |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | LZA | Substantially Equivalent | |
| K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | LZA | Substantially Equivalent | |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves | KGO | Substantially Equivalent | |
| K122999 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K023974 | ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K021855 | TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K993664 | SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES | LYZ | Substantially Equivalent | |
| K993605 | PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K993452 | GREEN POWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K993680 | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE | LYZ | Substantially Equivalent | |
| K990690 | POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES | LYY | Substantially Equivalent | |
| K990468 | LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING | LYY | Substantially Equivalent | |
| K983825 | NITRILE LATEX POWDER FREE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K983816 | NITRILE LATEX POWDERED EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K932521 | POWDERFREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K913409 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043848 | 3003564842 | TOP GLOVE SDN. BHD. | LOT 4969,JALAN TERATAI,BATU 6, KLANG Selangor 41050 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