GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS— 510(k) K993725
Substantially EquivalentHartalega Sdn Bhd
FDA 510(k) clearance K993725 for GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS, Substantially Equivalent on 1999-11-23. Applicant: Hartalega Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Hartalega 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
- Kuala Lumpur, 52100, MY
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More clearances from Hartalega Sdn Bhd
view all- K201748 — Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
- K201531 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K200897 — Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
- K180645 — Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
- K180786 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
Data sourced from openFDA. This site is unofficial and independent of the FDA.