TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K994250
Substantially EquivalentTekmedic (M) Sdn Bhd
FDA 510(k) clearance K994250 for TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2000-02-07. 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
- Alexandria, VA, US
Recent devices under product code LYY
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- 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 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)
- K121591 — FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.