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FDA 510(k)

POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)

K-Number: K980037 · 1998-02-09

ApplicantSri Johani Sdn. Bhd.
Decision Date1998-02-09
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Johani Sdn. Bhd.. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K980037. 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 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)?

POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Sri Johani Sdn. Bhd.. The 510(k) number is K980037.

When did POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) receive FDA 510(k) clearance?

POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) received FDA 510(k) clearance on 1998-02-09, under 510(k) number K980037.

Who is the listed applicant for POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)?

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

What is the FDA product code for POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)?

The FDA product code for POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) is LYY.

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Other records listing Sri Johani 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.

K993454POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)K993457POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]K993458POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)K981039POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)K980038POWDERFREE GREEN LATEX EXAMINATION GLOVESK980039POWDERED GREEN LATEX EXAMINATION GLOVES

View all 23 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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