POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM— 510(k) K990501
Substantially EquivalentFlexitech Sdn. Bhd.
FDA 510(k) clearance K990501 for POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM, Substantially Equivalent on 1999-04-02. Applicant: Flexitech Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Flexitech 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
- Klang, Selangor, MY
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 Flexitech Sdn. Bhd.
view all- K994416 — POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K994354 — POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K990495 — POWDER FREE NITRILE EXAMINATION GLOVES
- K990499 — PREPOWDERED NITRILE EXAMINATION GLOVES
- K990502 — PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.