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

Hartalega NGC Sdn. Bhd. · Predicate Candidate Screening

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

103 daysmedian FDA review time

213 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260558	Latex Powder Free Surgical Gloves Tested for Use with Chemot	Hartalega NGC Sdn. Bhd.	2026-07-28	159	0
K254285	Nitrile Powder Free Examination Gloves Tested for Use with C	Hartalega NGC Sdn. Bhd.	2026-07-20	201	0
K260867	Nitrile Powder Free Examination Gloves Tested for Use with C	Hartalega NGC Sdn. Bhd.	2026-06-17	92	0
K250861	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2025-10-23	216	0
K251319	Sterile Nitrile Powder Free Examination Glove Tested for Use	Hartalega NGC Sdn. Bhd.	2025-07-30	92	0
K243818	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2025-01-08	27	0
K223437	Biodegradable Nitrile Powder Free Examination Glove Tested f	Hartalega NGC Sdn. Bhd.	2023-05-17	184	0
K222225	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2022-11-11	109	0
K221718	Polyisoprene Powder Free Surgical Glove Tested for Use with	Hartalega NGC Sdn. Bhd.	2022-09-24	103	0
K214074	Latex Powder Free Surgical Glove with Protein Labeling Claim	Hartalega NGC Sdn. Bhd.	2022-05-26	150	0
K211758	Polychloroprene Powder Free Examination Glove Tested for Use	Hartalega NGC Sdn. Bhd.	2021-08-03	57	0
K201772	Nitrile Powder Free Examination Gloves with Low Dermatitis P	Hartalega NGC Sdn. Bhd.	2020-08-25	57	0
K201530	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2020-08-05	58	0
K200581	Biodegradable Nitrile Powder Free Examination Gloves Tested	Hartalega NGC Sdn. Bhd.	2020-04-25	51	0
K200019	Nitrile Powder Free Examination Gloved Tested for Use with C	Hartalega NGC Sdn. Bhd.	2020-04-06	94	1
K192232	Nitrile Powder Free Examination Glove with Low Dermatitis Po	Hartalega NGC Sdn. Bhd.	2019-11-08	84	0
K190454	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2019-09-26	213	0
K183536	Latex Powder Free Surgical Glove with Protein Labeling Claim	Hartalega NGC Sdn. Bhd.	2019-08-16	240	0
K183389	Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder	Hartalega NGC Sdn. Bhd.	2019-06-28	204	0
K172442	Nitrile Powder Free Examination Glove with Low Dermatitis Po	Hartalega NGC Sdn. Bhd.	2017-11-06	87	0
K170794	Nitrile Powder Free Examination Glove Tested for Use with Ch	Hartalega NGC Sdn. Bhd.	2017-06-30	106	0
K162646	Nitrile Powder Free Examination Glove with Low Dermatitis Po	Hartalega NGC Sdn. Bhd.	2017-03-03	162	0
K162923	NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CH	Hartalega NGC Sdn. Bhd.	2017-02-06	111	0
K151997	Nitrile Powder Free Examination Gloves Tested for Use with C	Hartalega NGC Sdn. Bhd.	2016-03-31	255	0
K151836	NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER	Hartalega NGC Sdn. Bhd.	2015-10-21	107	0
K151684	Nitrile Powder Free Examination Glove with Low Dermatitis Po	Hartalega NGC Sdn. Bhd.	2015-09-18	88	0
K151343	Nitrile Powder Free Examination Gloves Tested for Use with C	Hartalega NGC Sdn. Bhd.	2015-08-24	97	0
K150110	Nitrile Powder Free Examination Glove with Colloidal Oatmeal	Hartalega NGC Sdn. Bhd.	2015-04-23	93	0
K143419	Patient Examination Gloves	Hartalega NGC Sdn. Bhd.	2015-03-06	98	0
K140890	NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK	Hartalega NGC Sdn. Bhd.	2014-07-24	107	0
K140610	NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / V	Hartalega NGC Sdn. Bhd.	2014-06-20	102	0

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