Comfort Rubber Gloves Industries Sdn Bhd
TAIPING Perak, MY
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD appears in FDA device records in TAIPING Perak, MY. FDA records list 15 510(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 15 510(k) clearances for Comfort Rubber Gloves Industries Sdn Bhd between 1994 and 2025. The busiest year on record is 2000, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | LYY | Substantially Equivalent | |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | LZA | Substantially Equivalent | |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | LZA | Substantially Equivalent | |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | LZA | Substantially Equivalent | |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K171541 | Powder Free Nitrile Examination Gloves (Orange) | LZA | Substantially Equivalent | |
| K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) | LZA | Substantially Equivalent | |
| K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K101917 | COMFORT RUBBER GLOVES IND.SDN.BHD. | LYY | Substantially Equivalent | |
| K002065 | PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR | LYY | Substantially Equivalent | |
| K001042 | COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE | LYY | Substantially Equivalent | |
| K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | LYY | Substantially Equivalent | |
| K935256 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005568780 | 3003116055 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | LOT 821, JALAN MATANG, TAIPING Perak 34750 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