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FDA 510(k)

MULTI-COMFORT POWDER FREE

K-Number: K935033 · 1994-02-02

ApplicantPerusahaan Intan Emas Sdn. Bhd.
Decision Date1994-02-02
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTI-COMFORT POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Intan Emas Sdn. Bhd.. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K935033. 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 MULTI-COMFORT POWDER FREE?

MULTI-COMFORT POWDER FREE is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is Perusahaan Intan Emas Sdn. Bhd.. The 510(k) number is K935033.

When did MULTI-COMFORT POWDER FREE receive FDA 510(k) clearance?

MULTI-COMFORT POWDER FREE received FDA 510(k) clearance on 1994-02-02, under 510(k) number K935033.

Who is the listed applicant for MULTI-COMFORT POWDER FREE?

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

What is the FDA product code for MULTI-COMFORT POWDER FREE?

The FDA product code for MULTI-COMFORT POWDER FREE is LYY.

Related Clinical Trials

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Other records listing Perusahaan Intan Emas 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.

K982691MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K925363HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVESK892074PATIENT EXAMINATION GLOVES (LATEX)

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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