FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)— 510(k) K121591
Substantially EquivalentTekmedic (M) Sdn Bhd
FDA 510(k) clearance K121591 for FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY), Substantially Equivalent on 2012-10-11. Applicant: Tekmedic (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Tekmedic (M) 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
- Jetty, Tanjung Kling, Malacca, 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 Tekmedic (M) Sdn Bhd
view all- K121592 — POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
- K121594 — COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
- K121192 — NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
- K100694 — COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
- K013317 — TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.