Aegis Personal Protective Suit

Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra, extra large size.

Registry build 21.09.26
318manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OEA
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Evereast Medical Products Group Co., Ltd. Changyuan Henan Contract manufacturer 30
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23

Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown

Record

Regulatory record for Aegis Personal Protective Suit
Listed by CAO Group, Inc., United States
FDA product code OEA
Device type Non-Surgical Gown
Device class Class 1
Regulation 21 CFR 878.4040
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-04-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number
Packaging Pack of 3

Catalogue Numbers

Catalogue numbers for Aegis Personal Protective Suit
Catalogue number Size Status
005-00076 In distribution
005-00062 In distribution
005-00079 In distribution
005-00078 In distribution
005-00069 In distribution
005-00077 In distribution
005-00080 In distribution
005-00055 In distribution
005-00074 In distribution
005-00071 In distribution
005-00053 In distribution
005-00082 In distribution
005-00057 In distribution
005-00052 In distribution
005-00063 In distribution
005-00059 In distribution
005-00060 In distribution
005-00075 In distribution
005-00051 In distribution
005-00054 In distribution
005-00068 In distribution
005-00081 In distribution
005-00056 In distribution
005-00058 In distribution
005-00072 In distribution
005-00073 In distribution
005-00083 In distribution
005-00070 In distribution
005-00064 In distribution
005-00061 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 230
Henry Schein Henry Schein, Inc. 144
Darby Dental Supply, LLC Darby Dental Supply, LLC 118
Medline Medline Industries, Inc. 99
Precaution/Isolation Gown Standard Textile Co., Inc. 83
PremierPro Prestige Ameritech 74
Alleset GRI Medical & Electronic Technology Co., Ltd. 71
Medicom Safewear AMD Medicom Inc. 70
Maytex Maytex Corp. 67
Precept® Precept Medical Products, Inc. 61
3D Dental-Essentials 3D Dental Designs AND Development, LLC 56
Halyard O&M Halyard, Inc. 53

Showing 12 of 230. All products under Non-Surgical Gown

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer