Atlas FDA

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

Careplus (M) Sdn Bhd · Predicate Candidate Screening

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

168 daysmedian FDA review time
410 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211621Latex Surgical Gloves, Powder Free with Protein claim (50 miCareplus (M) Sdn Bhd2021-10-061330
K201857Powder Free Nitrile Examination Glove Black and Dual Color WCareplus (M) Sdn Bhd2021-08-204100
K203705Latex Examination Glove, Powder free with Protein Content LaCareplus (M) Sdn Bhd2021-08-202450
K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves withCareplus (M) Sdn Bhd2021-08-031460
K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with PCareplus (M) Sdn Bhd2021-06-241120
K202765ENCORE Latex Textured Surgical Gloves, Powder Free with ProtCareplus (M) Sdn Bhd2021-05-272480
K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHCareplus (M) Sdn Bhd2017-07-242850
K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd2016-02-251680
K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)Careplus (M) Sdn Bhd2015-02-091310
K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd2015-01-161070

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