FDA 510(k)

CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G

Q: Who is the listed applicant for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G?

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

Q: What is the FDA product code for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G?

The FDA product code for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G is LYY.

K-Number: K980754 · 1998-05-18

ApplicantCrocker Industrial Resources Sdn. Bhd.

Decision Date1998-05-18

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G is the device name listed in this FDA 510(k) record. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K980754. 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 CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G?

CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. The 510(k) number is K980754.

When did CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G receive FDA 510(k) clearance?

CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G received FDA 510(k) clearance on 1998-05-18, under 510(k) number K980754.

Who is the listed applicant for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G?

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

What is the FDA product code for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G?

The FDA product code for CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G is LYY.

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Other records listing Crocker Industrial Resources Sdn. Bhd. as applicant

K960842LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)K943858POWDER FREE (SILICONIZED) EXAM GLOVES K935980CIR LATEX GLOVES (CIR GOLD SEAL)K924419CIR LATEX GLOVES K892465NON-STERILE PATIENT EXAMINATION GLOVES

Related Devices (Code: LYY)

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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.