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

Yty Industry (Manjung) Sdn Bhd · Predicate Candidate Screening

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

78 daysmedian FDA review time

274 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K220644	Non-sterile, Powder Free, ambidextrous, textured, beaded cuf	Yty Industry (Manjung) Sdn Bhd	2023-03-25	386
K202536	Non-sterile, Powder Free Nitrile Examination Aloe Vera Glove	Yty Industry (Manjung) Sdn Bhd	2021-08-11	344
K200453	NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DER	Yty Industry (Manjung) Sdn Bhd	2020-05-01	67
K182383	Non-Sterile, PF Nitrile Examination Gloves, Tested for Use w	Yty Industry (Manjung) Sdn Bhd	2019-03-19	200
K171104	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested	Yty Industry (Manjung) Sdn Bhd	2017-08-25	134
K162095	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested	Yty Industry (Manjung) Sdn Bhd	2016-11-02	97
K143289	NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, G	Yty Industry (Manjung) Sdn Bhd	2015-08-18	274
K143055	Non-Sterile, Powder Free Scented Blue Nitrile Examination Gl	Yty Industry (Manjung) Sdn Bhd	2015-02-12	112
K142283	Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, B	Yty Industry (Manjung) Sdn Bhd	2015-01-16	154
K133123	NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES -	Yty Industry (Manjung) Sdn Bhd	2014-05-30	242
K111248	NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINA	Yty Industry (Manjung) Sdn Bhd	2011-12-01	212
K101820	NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVE	Yty Industry (Manjung) Sdn Bhd	2011-03-03	246
K061553	NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES	Yty Industry (Manjung) Sdn Bhd	2006-07-17	42
K052502	NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GL	Yty Industry (Manjung) Sdn Bhd	2005-11-18	66
K033887	NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLY	Yty Industry (Manjung) Sdn Bhd	2004-03-02	78
K031384	MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURET	Yty Industry (Manjung) Sdn Bhd	2003-06-17	47
K030164	NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIO	Yty Industry (Manjung) Sdn Bhd	2003-03-07	50
K024355	EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAM	Yty Industry (Manjung) Sdn Bhd	2003-02-03	35
K023577	POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR CO	Yty Industry (Manjung) Sdn Bhd	2002-12-06	44
K023590	POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES	Yty Industry (Manjung) Sdn Bhd	2002-11-08	14
K011376	EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED L	Yty Industry (Manjung) Sdn Bhd	2001-05-25	21
K991742	NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION G	Yty Industry (Manjung) Sdn Bhd	1999-06-21	31
K990013	EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATI	Yty Industry (Manjung) Sdn Bhd	1999-03-23	78
K983608	EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING	Yty Industry (Manjung) Sdn Bhd	1998-11-05	22
K974191	EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE	Yty Industry (Manjung) Sdn Bhd	1997-12-24	44
K974518	NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED	Yty Industry (Manjung) Sdn Bhd	1997-12-12	10
K892611	PATIENT EXAMINATION GLOVES (LATEX)	Yty Industry (Manjung) Sdn Bhd	1989-07-14	95

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