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FDA 510(k)

LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM

K-Number: K030333 · 2003-03-21

ApplicantPerusahaan Getah Asas Sdn. Bhd.
Decision Date2003-03-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030333. 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 LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM?

LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K030333.

When did LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030333.

Who is the listed applicant for LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM?

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

What is the FDA product code for LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM?

The FDA product code for LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM is LYY.

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Other records listing Perusahaan Getah Asas 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.

K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGK042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILEK032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDK031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLOREDK031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLOREDK031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE

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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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