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FDA 510(k)

GLOVE SEAL & SET-RITE

K-Number: K954063 · 1996-06-05

ApplicantContract Latex Dippers Sdn Bhd
Decision Date1996-06-05
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE SEAL & SET-RITE is the device name listed in this FDA 510(k) record. The listed applicant is Contract Latex Dippers Sdn Bhd. It received FDA 510(k) clearance on 1996-06-05 under 510(k) number K954063. 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 GLOVE SEAL & SET-RITE?

GLOVE SEAL & SET-RITE is a medical device that received FDA 510(k) clearance on 1996-06-05. The listed applicant is Contract Latex Dippers Sdn Bhd. The 510(k) number is K954063.

When did GLOVE SEAL & SET-RITE receive FDA 510(k) clearance?

GLOVE SEAL & SET-RITE received FDA 510(k) clearance on 1996-06-05, under 510(k) number K954063.

Who is the listed applicant for GLOVE SEAL & SET-RITE?

The FDA 510(k) record lists Contract Latex Dippers Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVE SEAL & SET-RITE?

The FDA product code for GLOVE SEAL & SET-RITE 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 Contract Latex Dippers 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.

K011012POWDER FREE NITRILE EXAMINATION GLOVEK983568OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PERK955947OSTAR EXAMINATION GLOVESK934316GLOVE SEAL, POWDER FREE LATEX 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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