MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX— 510(k) K022815
Substantially EquivalentPt. Smartglove Indonesia
FDA 510(k) clearance K022815 for MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX, Substantially Equivalent on 2003-02-13. Applicant: Pt. Smartglove Indonesia. Device class: 1.
Clearance details
- Applicant
- Pt. Smartglove Indonesia
- 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
- Tg Morawa-Deli Serdang Utara, ID
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 Pt. Smartglove Indonesia
view all- K133699 — POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
- K101630 — POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
- K101293 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
- K092034 — POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
- K041848 — POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.