AOSHANG earloop
by Tianjin Aoshang Outdoor Equipment Co., Ltd. 6 variants
AOSHANG earloop is a Class II device made by Tianjin Aoshang Outdoor Equipment Co., Ltd., cleared under FDA 510(k) K210030 on 23 Apr 2021 and listed in FDA GUDID since 16 Jun 2021 (UDI-DI 06973532970360), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06973532970360 | Date16 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210030 | Date23 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 06973532970360
- FDA 510(k) database K210030
Across registries
- FDA 510(k) K210030 decided 23 Apr 2021 Active
- FDA GUDID UDI-DI 06973532970360 listed 16 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K210030
- Listed FDA GUDID 06973532970360
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aoshang
- Generic name
- Surgical/medical face mask, single-use
- Model / reference
- earloop
- Primary DI / UDI-DI
- 06973532970360
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical face mask, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FXX (Mask, Surgical).
- iMask Disposable Surgical Face Mask by PAC-DENT INC.
- Single-Use Medical Face Mask by Guangdong Horigen Mother & Baby Products Co., Ltd.
- Medical Face mask by Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
- SURGICAL FACE MASK by BUSSE HOSPITAL DISPOSABLES
- MEGATECH SCIENTIFIC FACE MASK by Megatech Scientific Pte, Ltd.
- OP-FACE MASK(MASQUE DE CHIRUGIE) by Roseburg SA
- MASKS, VARIOUS TYPES OF SURGICAL MASKS by Greene International Corp.
- Protective Face Mask for Medical Use by Shandong Shengquan New Material Co., Ltd.
- Disposable Medical Mask by Guangzhou Fuzelong Hygiene Material Co., Ltd.
- STS SHIELD WITH MASK by Innovative Outsourcing Solutions
Other devices from Tianjin Aoshang Outdoor Equipment Co., Ltd.
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