GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)— 510(k) K001047
Substantially EquivalentGuthrie Medicare Products (Melaka) Sdn Bhd
FDA 510(k) clearance K001047 for GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED), Substantially Equivalent on 2000-04-28. Applicant: Guthrie Medicare Products (Melaka) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Guthrie Medicare Products (Melaka) Sdn Bhd
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
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More clearances from Guthrie Medicare Products (Melaka) Sdn Bhd
view all- K003922 — NITRILE EXAMINATION GLOVES (POWERED)
- K003985 — POWDERFREE NITRILE PATIENT EXMINATION GLOVE
- K010078 — GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
- K010054 — GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K003872 — GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.