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

Safeskin Corp. — Predicate Candidate Screening

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

61 daysmedian FDA review time

199 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K993117	SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROT	Safeskin Corp.	2000-03-02	164
K994081	SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES	Safeskin Corp.	2000-01-18	46
K992830	SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-F	Safeskin Corp.	1999-10-27	65
K992210	SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES	Safeskin Corp.	1999-09-10	71
K992162	SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR U	Safeskin Corp.	1999-08-30	66
K992062	SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES	Safeskin Corp.	1999-08-25	68
K991951	SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINAT	Safeskin Corp.	1999-07-26	46
K991317	POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS	Safeskin Corp.	1999-05-21	32
K970899	SAFESKIN POWDERED EXAMINATION GLOVE	Safeskin Corp.	1997-05-06	56
K962139	SAFESKIN	Safeskin Corp.	1996-12-19	199
K953015	SAFESKIN SUPRA	Safeskin Corp.	1995-08-28	60
K952993	SAFESKIN SUPRA	Safeskin Corp.	1995-08-28	61
K952793	SAFESKIN	Safeskin Corp.	1995-08-11	53
K952851	SAFESKIN	Safeskin Corp.	1995-08-11	51
K932404	NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE	Safeskin Corp.	1994-05-18	370
K932405	NITRILE RUBBER EXAMINATION GLOVES (POWERED)	Safeskin Corp.	1994-05-18	370
K895807	STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'	Safeskin Corp.	1989-12-18	80
K894497	LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)	Safeskin Corp.	1989-11-16	125
K895669	POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES	Safeskin Corp.	1989-11-03	45
K894354	SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES	Safeskin Corp.	1989-08-23	40
K894311	MODIFIED PATIENT EXAMINATION GLOVES	Safeskin Corp.	1989-08-10	27
K891435	PATIENT EXAMINATION GLOVES (LATEX)	Safeskin Corp.	1989-05-12	58
K891264	PATIENT EXAMINATION GLOVES (LATEX)	Safeskin Corp.	1989-04-13	36
K880446	SAFESKIN STERILE SURGEONS GLOVES	Safeskin Corp.	1988-06-01	120

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