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FDA 510(k)

MULTIPLE

K-Number: K945164 · 1995-02-03

ApplicantProtection Gloves Sdn. Bhd.
Decision Date1995-02-03
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is Protection Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 1995-02-03 under 510(k) number K945164. 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 MULTIPLE?

MULTIPLE is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Protection Gloves Sdn. Bhd.. The 510(k) number is K945164.

When did MULTIPLE receive FDA 510(k) clearance?

MULTIPLE received FDA 510(k) clearance on 1995-02-03, under 510(k) number K945164.

Who is the listed applicant for MULTIPLE?

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

What is the FDA product code for MULTIPLE?

The FDA product code for MULTIPLE 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

Related PubMed Literature

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.

PMID: 42290427Reliability and Consistency Analysis of Multiple Instruments for Scoliosis Screening in Adolescent Males: A Comparative Study of Instrument Accuracy.Studies in health technology and informatics ()PMID: 30115367The multiple arrhythmia dataset evaluation database (M.A.D.A.E.).Journal of electrocardiology ()

Other records listing Protection Gloves 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.

K010854CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)K011231CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREENK000668POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRAK000667POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM

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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