Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
FDA 510(k) clearance K222993 · decided 2023-08-18
Clearance details
- K-number
- K222993
- Device name
- Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
- Applicant
- Sentienx Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2022-09-28
- Decision date
- 2023-08-18
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kulim, MY
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.