VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)— 510(k) K891726

Name: FDA 510(k) clearance K891726
Creator: U.S. Food and Drug Administration
Published: 1989-05-12

Substantially Equivalent

Baldur Systems Corp.

FDA 510(k) clearance K891726 for VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.), Substantially Equivalent on 1989-05-12. Applicant: Baldur Systems Corp.. Device class: 1.

Clearance details

Applicant: Baldur Systems Corp.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-03-23
Decision date: 1989-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K241252 — Disposable Vinyl Examination Gloves2024-05-20
K230046 — Vinyl examination gloves2023-03-25

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K892684 — PATIENT EXAMINATION GLOVES (LATEX)1989-09-11
K891728 — LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)1989-05-25
K891727 — LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)1989-05-12

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