Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Comfort Rubber Gloves Industries Sdn. Bhd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
242 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 | 109 | 0 |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-10-25 | 268 | 0 |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile L | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-08-06 | 68 | 0 |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Ch | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020-06-19 | 242 | 0 |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020-04-15 | 82 | 0 |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with C | Comfort Rubber Gloves Industries Sdn. Bhd. | 2019-06-27 | 162 | 0 |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with C | Comfort Rubber Gloves Industries Sdn. Bhd. | 2018-05-15 | 82 | 0 |
| K171541 | Powder Free Nitrile Examination Gloves (Orange) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-09-20 | 117 | 0 |
| K162405 | Powder Free Nitrile Examination Gloves Tested For Use With C | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-03-28 | 211 | 0 |
| K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | Comfort Rubber Gloves Industries Sdn. Bhd. | 2011-06-15 | 134 | 0 |
| K101917 | COMFORT RUBBER GLOVES IND.SDN.BHD. | Comfort Rubber Gloves Industries Sdn. Bhd. | 2010-10-29 | 112 | 0 |
| K002065 | PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 | Comfort Rubber Gloves Industries Sdn. Bhd. | 2000-08-22 | 46 | 0 |
| K001042 | COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTE | Comfort Rubber Gloves Industries Sdn. Bhd. | 2000-05-23 | 53 | 0 |
| K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | Comfort Rubber Gloves Industries Sdn. Bhd. | 1998-04-23 | 150 | 0 |
| K935256 | PATIENT EXAMINATION GLOVES | Comfort Rubber Gloves Industries Sdn. Bhd. | 1994-03-09 | 128 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda