Regard™
Bundle Isolation Contact
8manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Shaoxing Songqiao Textile Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 26 |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Dongguan Luda Industrial Co., Ltd. | Dongguan | Guangdong | Manufacturer | 8 |
| Hefei Juniushangmao Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 7 |
Record
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | PXC |
| Device type | Personal Protection Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Premarket notification | Exempt |
| Record published | 2024-10-02 |
| Record revised | 2021-09-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 10, pack of 5 |
| Distribution end date | 2025-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GS00177R | Withdrawn | |
| GS00177Q | Withdrawn | |
| GS00175O | Withdrawn | |
| GS00401B | Withdrawn | |
| GS00175L | Withdrawn | |
| GS00401A | Withdrawn | |
| GS00809G | Withdrawn | |
| GS00175P | Withdrawn | |
| GS00175Q | Withdrawn | |
| GS00175N | Withdrawn | |
| GS00175M | Withdrawn | |
| GS00177O | Withdrawn | |
| GS00176N | Withdrawn | |
| GS00178F | Withdrawn | |
| GS00176P | Withdrawn | |
| GS00178E | Withdrawn | |
| GS00176O | Withdrawn | |
| GS00177P | Withdrawn | |
| GS00176M | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedSource Gloves | Medsource International, LLC | 7 |
| Bosma Enterprises | Bosma Enterprises | 5 |
| Afflink | Bosma Enterprises | 4 |
| Stradis Healthcare | Stradis Healthcare | 4 |
| Stradis Medical, LLC. | Stradis Healthcare | 2 |
| NAR | North American Rescue, LLC. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
| Curaplex | Bound Tree Medical, LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.