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FDA 510(k)

SUNNY TEX (PATIENT EXAMINATION GLOVES)

K-Number: K892021 · 1989-09-15

ApplicantP.T. Indotama Megah Indah Rubber
Decision Date1989-09-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUNNY TEX (PATIENT EXAMINATION GLOVES) is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Indotama Megah Indah Rubber. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K892021. 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 SUNNY TEX (PATIENT EXAMINATION GLOVES)?

SUNNY TEX (PATIENT EXAMINATION GLOVES) is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is P.T. Indotama Megah Indah Rubber. The 510(k) number is K892021.

When did SUNNY TEX (PATIENT EXAMINATION GLOVES) receive FDA 510(k) clearance?

SUNNY TEX (PATIENT EXAMINATION GLOVES) received FDA 510(k) clearance on 1989-09-15, under 510(k) number K892021.

Who is the listed applicant for SUNNY TEX (PATIENT EXAMINATION GLOVES)?

The FDA 510(k) record lists P.T. Indotama Megah Indah Rubber as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNNY TEX (PATIENT EXAMINATION GLOVES)?

The FDA product code for SUNNY TEX (PATIENT EXAMINATION GLOVES) is LYY.

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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.

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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.

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