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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shield Gloves Manufacturer (M) Sdn Bhd · Predicate Candidate Screening

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

55 daysmedian FDA review time
98 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011613POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER Shield Gloves Manufacturer (M) Sdn Bhd2001-09-171150
K000156SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEShield Gloves Manufacturer (M) Sdn Bhd2000-02-18300
K000217ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDEREDShield Gloves Manufacturer (M) Sdn Bhd2000-02-18250
K992417ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13550
K992418ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINAShield Gloves Manufacturer (M) Sdn Bhd1999-09-13550
K992419ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINAShield Gloves Manufacturer (M) Sdn Bhd1999-09-13550
K991743ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEShield Gloves Manufacturer (M) Sdn Bhd1999-06-23331
K991744SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATIShield Gloves Manufacturer (M) Sdn Bhd1999-06-23330
K991745ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATIOShield Gloves Manufacturer (M) Sdn Bhd1999-06-23330
K991746ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATIONShield Gloves Manufacturer (M) Sdn Bhd1999-06-23330
K972757ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINAShield Gloves Manufacturer (M) Sdn Bhd1997-10-29980
K953496ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXShield Gloves Manufacturer (M) Sdn Bhd1995-09-08440
K952589ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATIShield Gloves Manufacturer (M) Sdn Bhd1995-08-11670
K945031ROYALSHIELD NON-STERILE POWDER-FREEShield Gloves Manufacturer (M) Sdn Bhd1995-01-11900
K943807ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVShield Gloves Manufacturer (M) Sdn Bhd1994-09-29560
K943043ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUMShield Gloves Manufacturer (M) Sdn Bhd1994-09-26910
K943044ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRYShield Gloves Manufacturer (M) Sdn Bhd1994-09-26910
K942940ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVESShield Gloves Manufacturer (M) Sdn Bhd1994-08-01400

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