FDA 510(k)

ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE

K-Number: K972757 · 1997-10-29

ApplicantShield Gloves Manufacturer (M) Sdn Bhd

Decision Date1997-10-29

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Shield Gloves Manufacturer (M) Sdn Bhd. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K972757. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE?

ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Shield Gloves Manufacturer (M) Sdn Bhd. The 510(k) number is K972757.

When did ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE receive FDA 510(k) clearance?

ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE received FDA 510(k) clearance on 1997-10-29, under 510(k) number K972757.

Who is the listed applicant for ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE?

The FDA 510(k) record lists Shield Gloves Manufacturer (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE?

The FDA product code for ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE is LZA.

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Other records listing Shield Gloves Manufacturer (M) Sdn Bhd as applicant

K011613POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE K000217ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W K000156SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES K992418ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI K992417ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR K992419ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR

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Related Devices (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.