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 28 Jul 2021 (UDI-DI 06973532970216), 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 | Number06973532970216 | Date28 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210030 | Date23 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 06973532970216
- FDA 510(k) database K210030
Across registries
- FDA 510(k) K210030 decided 23 Apr 2021 Active
- FDA GUDID UDI-DI 06973532970216 listed 28 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K210030
- Listed FDA GUDID 06973532970216
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- Withdrawn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
- 06973532970216
- 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).
- SURGICAL FACE MASK by Anago, Inc.
- Medline Surgical Face Mask and Medline Procedural Face Mask by MEDLINE INDUSTRIES, INC.
- Disposable Surgical Mask by Unisources Group, LLC
- Single-Use Surgical Mask With Ear Loop by Qiqihar Hengxin Medical Supplies, Ltd.
- Disposable Medical Surgical Face Masks by Guangdong Kaidi Garments Co., Ltd
- Medical surgical mask by GUANGDONG KINGFA SCI. & TECH. CO., LTD.
- ICU Health Surgical Mask by Plastikon Industries
- I-SPOSE EYE SHIELD by Products For Medicine
- DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR by Creative Contract (M) Sdn Bhd
- Savewo ClassicMASK by Savewo Limited
Other devices from Tianjin Aoshang Outdoor Equipment Co., Ltd.
See all devices from Tianjin Aoshang Outdoor Equipment Co., Ltd. →