Comfort Rubber Gloves Industries Sdn. Bhd.: FDA clearances and approvals
Comfort Rubber Gloves Industries Sdn. Bhd. has 15 FDA 510(k) clearances (first 1994, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 117 days. Since 2017 its median was 117 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 164 |
| 2018 | 1 | 82 |
| 2019 | 1 | 162 |
| 2020 | 2 | 162 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 168 |
| 2025 | 1 | 109 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Comfort Rubber Gloves Industries Sdn. Bhd.'s cleared 510(k)s took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 8 | 8 |
| LYY | Latex Patient Examination Glove | 6 | 6 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (15)
Most recent Comfort Rubber Gloves Industries Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | LYY | 2025-04-29 | 109 |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | LZA | 2024-10-25 | 268 |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | LZA | 2024-08-06 | 68 |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | 2020-06-19 | 242 |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2020-04-15 | 82 |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | LZA | 2019-06-27 | 162 |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | 2018-05-15 | 82 |
| K171541 | Powder Free Nitrile Examination Gloves (Orange) | LZA | 2017-09-20 | 117 |
| 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 | 2017-03-28 | 211 |
| K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | LZA | 2011-06-15 | 134 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Comfort Rubber Gloves Industries Sdn. Bhd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Comfort Rubber Gloves Industries Sdn. Bhd. have?
Comfort Rubber Gloves Industries Sdn. Bhd. has 15 FDA 510(k) clearances (first 1994, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Comfort Rubber Gloves Industries Sdn. Bhd.'s 510(k)s?
The median time from FDA receipt to decision across Comfort Rubber Gloves Industries Sdn. Bhd.'s cleared 510(k)s is 117 days. Since 2017: 117 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Comfort Rubber Gloves Industries Sdn. Bhd. make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 8); LYY (Latex Patient Examination Glove, 6); LZC (Medical Glove, Specialty, 1).
Has Comfort Rubber Gloves Industries Sdn. Bhd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Comfort Rubber Gloves Industries Sdn. Bhd. Related entities may recall under other names.
Next steps
- See all 15 Comfort Rubber Gloves Industries Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Comfort Rubber Gloves Industries Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.