Surgical Cotton Gloves
FDA 510(k) K900425 · Allo Pro Corp.
510(k) numberK900425
Submission
- Device name
- Surgical Cotton Gloves
- Applicant
- Allo Pro Corp.
Clearwater, FL, US - Received
- January 30, 1990
- Decision date
- September 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Surgical Cotton Gloves cleared by the FDA?
Surgical Cotton Gloves (K900425) received a 510(k) decision of Substantially Equivalent on September 7, 1990, 220 days after the submission was received.
What is the product code of K900425?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.