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

FYE · Predicate Candidate Screening

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

64 daysmedian FDA review time

308 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K932731	BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN	Johnson & Johnson Medical, Inc.	1994-04-11	308
K912790	SURGICAL GOWN	Unicor Federal Dept. of Justice	1991-09-19	86
K910920	PROTEKT GLOVES	Intermedics Orthopedics	1991-05-15	71
K910941	LIFELINER SURGICAL GLOVE	Depuy-Raynham	1991-05-09	64
K895667	STERILE SURGICAL GOWN	Clinitech, Inc.	1989-10-13	23
K895235	VARIOUS DISPOSABLE SURGICAL GARMENTS	Protect Corp. of Indiana, Inc.	1989-09-19	43
K894760	CLOTHINGUARD	Barrier Concepts, Inc.	1989-08-18	22

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