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FDA 510(k)

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED

K-Number: K974518 · 1997-12-12

ApplicantYty Industry (Manjung) Sdn Bhd
Decision Date1997-12-12
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED is the device name listed in this FDA 510(k) record. The listed applicant is Yty Industry (Manjung) Sdn Bhd. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K974518. 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 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED?

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Yty Industry (Manjung) Sdn Bhd. The 510(k) number is K974518.

When did NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED receive FDA 510(k) clearance?

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED received FDA 510(k) clearance on 1997-12-12, under 510(k) number K974518.

Who is the listed applicant for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED?

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

What is the FDA product code for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED?

The FDA product code for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED is LYY.

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Other records listing Yty Industry (Manjung) 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.

K220644Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy DrugsK202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl CitrateK200453NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-ACK182383Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-BlueK171104Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

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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

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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