POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)— 510(k) K003934
Substantially EquivalentSeltom Pacific Sdn. Bhd.
FDA 510(k) clearance K003934 for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS), Substantially Equivalent on 2001-01-26. Applicant: Seltom Pacific Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Seltom Pacific 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
- Selangor Darul Ehsan, MY
Recent devices under product code LYY
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- 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 Seltom Pacific Sdn. Bhd.
view all- K011924 — POWDERED BLUE NITRILE EXAMINATION GLOVES
- K011922 — POWDERED LATEX EXAMINATION GLOVES
- K991777 — LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
- K991778 — LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
- K991776 — NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.