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

Sri Johani Sdn. Bhd. — Predicate Candidate Screening

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

42 daysmedian FDA review time

67 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K993454	POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEI	Sri Johani Sdn. Bhd.	1999-12-03	51
K993457	POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [5	Sri Johani Sdn. Bhd.	1999-12-02	50
K993458	POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)	Sri Johani Sdn. Bhd.	1999-11-10	28
K981039	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	Sri Johani Sdn. Bhd.	1998-04-21	33
K980039	POWDERED GREEN LATEX EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1998-02-09	35
K980037	POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)	Sri Johani Sdn. Bhd.	1998-02-09	35
K980038	POWDERFREE GREEN LATEX EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1998-02-09	35
K974886	POWDERED GREEN NITRILE EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1998-01-30	31
K974887	POWDERFREE GREEN NITRILE EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1998-01-29	30
K974185	POLYMER NITRILE EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1997-12-18	42
K974183	POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-12-18	42
K974184	HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-12-18	42
K974182	POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-12-17	41
K973903	POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-12-17	64
K973904	POLYMER LATEX EXAMINATION GLOVES	Sri Johani Sdn. Bhd.	1997-12-17	64
K973801	HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-11-21	46
K973815	HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)	Sri Johani Sdn. Bhd.	1997-11-21	45
K973059	PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)	Sri Johani Sdn. Bhd.	1997-11-07	81
K973058	PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)	Sri Johani Sdn. Bhd.	1997-11-07	81
K945247	POWDERFREE LATEX EXAMINATION GLOVE	Sri Johani Sdn. Bhd.	1995-01-02	67
K900869	NON-STERILE LATEX PROCEDURE GLOVE	Sri Johani Sdn. Bhd.	1990-03-09	14
K900868	STERILE LATEX EXAMINATION GLOVE	Sri Johani Sdn. Bhd.	1990-03-09	14
K891378	PATIENT EXAMINATION GLOVES (LATEX)	Sri Johani Sdn. Bhd.	1989-03-29	20

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