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

Perusahaan Getah Asas Sdn. Bhd. · Predicate Candidate Screening

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

50 daysmedian FDA review time
82 days90th percentile
30clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd.2010-11-29630
K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOREDPerusahaan Getah Asas Sdn. Bhd.2004-12-16650
K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, Perusahaan Getah Asas Sdn. Bhd.2003-10-22824
K031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE Perusahaan Getah Asas Sdn. Bhd.2003-08-01660
K031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, Perusahaan Getah Asas Sdn. Bhd.2003-08-01530
K031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLOPerusahaan Getah Asas Sdn. Bhd.2003-06-26520
K031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COPerusahaan Getah Asas Sdn. Bhd.2003-06-26360
K031021CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GPerusahaan Getah Asas Sdn. Bhd.2003-06-13740
K030333LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH Perusahaan Getah Asas Sdn. Bhd.2003-03-21490
K030331ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODPerusahaan Getah Asas Sdn. Bhd.2003-03-21490
K030335ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLOREPerusahaan Getah Asas Sdn. Bhd.2003-03-03310
K024184POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLOREDPerusahaan Getah Asas Sdn. Bhd.2003-01-14260
K023262POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLPerusahaan Getah Asas Sdn. Bhd.2002-10-28280
K022701POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GPerusahaan Getah Asas Sdn. Bhd.2002-09-17340
K022601POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALPerusahaan Getah Asas Sdn. Bhd.2002-08-26210
K011271POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLOREDPerusahaan Getah Asas Sdn. Bhd.2001-05-08120
K010719POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLORPerusahaan Getah Asas Sdn. Bhd.2001-04-10290
K003737POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENPerusahaan Getah Asas Sdn. Bhd.2001-02-01590
K002314LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTEPerusahaan Getah Asas Sdn. Bhd.2000-08-17170
K001529POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROPerusahaan Getah Asas Sdn. Bhd.2000-06-12260
K991511POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)Perusahaan Getah Asas Sdn. Bhd.1999-06-03340
K984605POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COPerusahaan Getah Asas Sdn. Bhd.1999-01-25280
K984356NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PRPerusahaan Getah Asas Sdn. Bhd.1999-01-08320
K983729POWDER-FREE NITRILE PATIENT EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.1998-12-11500
K982806CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GPerusahaan Getah Asas Sdn. Bhd.1998-09-30500
K982440NITRILE PATIENT EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.1998-09-30780
K982807POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.1998-09-30500
K980916POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CPerusahaan Getah Asas Sdn. Bhd.1998-08-181600
K954365POWDER FREE LATEX EXAMINATION GLOVESPerusahaan Getah Asas Sdn. Bhd.1995-12-11840
K891640PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)Perusahaan Getah Asas Sdn. Bhd.1989-05-22660

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