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FDA 510(k)

PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)

K-Number: K934133 · 1994-01-07

ApplicantSupergrade Healthcare Products Sdn. Bhd.
Decision Date1994-01-07
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) is the device name listed in this FDA 510(k) record. The listed applicant is Supergrade Healthcare Products Sdn. Bhd.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K934133. 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 PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)?

PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Supergrade Healthcare Products Sdn. Bhd.. The 510(k) number is K934133.

When did PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) received FDA 510(k) clearance on 1994-01-07, under 510(k) number K934133.

Who is the listed applicant for PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)?

The FDA 510(k) record lists Supergrade Healthcare Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)?

The FDA product code for PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) is LYY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Supergrade Healthcare Products Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)K891232PATIENT EXAMINATION GLOVES

Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK230573Powder 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 BhdK223298Sterile 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.

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