Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Smart Glove Corporation Sdn. Bhd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213373 | Powder-Free Green Biodegradable Nitrile Examination Glove Te | Smart Glove Corporation Sdn. Bhd. | 2022-03-10 | 149 | 0 |
| K183280 | PowderFree White Blue Sterilized Nitrile Copolymer Examinati | Smart Glove Corporation Sdn. Bhd. | 2019-07-26 | 245 | 0 |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgica | Smart Glove Corporation Sdn. Bhd. | 2019-01-09 | 265 | 0 |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolyme | Smart Glove Corporation Sdn. Bhd. | 2018-08-08 | 195 | 0 |
| K171743 | Powder Free Pink Polychloroprene Copolymer Examination Glove | Smart Glove Corporation Sdn. Bhd. | 2017-11-17 | 158 | 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