FDA 510(k)

POWDER FREE (SILICONIZED) EXAM GLOVES

K-Number: K943858 · 1994-12-08

ApplicantCrocker Industrial Resources Sdn. Bhd.

Decision Date1994-12-08

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE (SILICONIZED) EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. It received FDA 510(k) clearance on 1994-12-08 under 510(k) number K943858. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER FREE (SILICONIZED) EXAM GLOVES?

POWDER FREE (SILICONIZED) EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1994-12-08. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. The 510(k) number is K943858.

When did POWDER FREE (SILICONIZED) EXAM GLOVES receive FDA 510(k) clearance?

POWDER FREE (SILICONIZED) EXAM GLOVES received FDA 510(k) clearance on 1994-12-08, under 510(k) number K943858.

Who is the listed applicant for POWDER FREE (SILICONIZED) EXAM GLOVES?

The FDA 510(k) record lists Crocker Industrial Resources Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE (SILICONIZED) EXAM GLOVES?

The FDA product code for POWDER FREE (SILICONIZED) EXAM GLOVES is LYY.

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Other records listing Crocker Industrial Resources Sdn. Bhd. as applicant

K980754CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G K960842LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)K935980CIR LATEX GLOVES (CIR GOLD SEAL)K924419CIR LATEX GLOVES K892465NON-STERILE PATIENT EXAMINATION GLOVES

Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.