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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

N.S. Uni-Gloves Sdn. Bhd. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

54 daysmedian FDA review time
123 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050765LANO-E POWDER-FREE NITRILE EXAMINATION GLOVEN.S. Uni-Gloves Sdn. Bhd.2005-04-08150
K013163UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVESN.S. Uni-Gloves Sdn. Bhd.2002-01-221230
K010881UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESN.S. Uni-Gloves Sdn. Bhd.2001-05-16540
K010879UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CN.S. Uni-Gloves Sdn. Bhd.2001-05-10480
K000689UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVESN.S. Uni-Gloves Sdn. Bhd.2000-04-28590
K000688UNIGLOVE NITRILE POWDERED EXAMINATION GLOVESN.S. Uni-Gloves Sdn. Bhd.2000-04-12430
K890965PATIENT EXAMINATION GLOVESN.S. Uni-Gloves Sdn. Bhd.1989-04-28600

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