ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
FDA 510(k) clearance K210724 · decided 2021-08-03
Clearance details
- K-number
- K210724
- Device name
- ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- Applicant
- Careplus (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2021-03-10
- Decision date
- 2021-08-03
- Days to decision
- 146 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
- Seremban, MY
- Third-party review
- No
- Expedited review
- No
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| Polyisoprene Surgical gloves (K240790) | Suzhou Colour-Way New Material Co., Ltd. | 2024-08-23 |
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| PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (K231973) | Ineo Tech Sdn Bhd | 2023-09-29 |
| Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 |
| Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K230578) | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 |
| Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (K230079) | Ansell Healthcare Products, LLC | 2023-08-23 |
| 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 (K222993) | Sentienx Sdn Bhd | 2023-08-18 |
Recalls involving this device
No recalls on record reference this clearance.