GUTHRIE PRIME POWDER-FREE— 510(k) K990228
Substantially EquivalentGuthrie Medicare Products (Melaka) Sdn Bhd
FDA 510(k) clearance K990228 for GUTHRIE PRIME POWDER-FREE, Substantially Equivalent on 1999-02-19. Applicant: Guthrie Medicare Products (Melaka) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Guthrie Medicare Products (Melaka) Sdn Bhd
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K230573 — Powder 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)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
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.