T7
Zippered Toga with Peel Away Face Shield
68manufacturers in China registered for this device type
12catalogue numbers in this listing
4510(k) clearances naming this product code
30recalls on this code
Who Else Makes It
Concentrated in Jiangsu (16), Hubei (13), Anhui (10). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Weihai Dishang Medical Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
Showing 12 of 68. All 68 manufacturers in China registered for Gown, Surgical
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200493 |
| Record published | 2020-05-11 |
| Record revised | 2021-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -20 to 40 °C |
| Packaging | Pack of 9, pack of 8, pack of 11, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0416-840-200 | In distribution | |
| 0416-830-100 | In distribution | |
| 0416-820-100 | In distribution | |
| 0416-840-100 | In distribution | |
| 0416-850-100 | In distribution | |
| 0416-740-200 | In distribution | |
| 0416-720-200 | In distribution | |
| 0416-850-200 | In distribution | |
| 0416-750-200 | In distribution | |
| 0416-830-200 | In distribution | |
| 0416-730-200 | In distribution | |
| 0416-820-200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 453 |
| Halyard | O&M Halyard, Inc. | 248 |
| Novo Health Services, LLC | Novo Health Services, LLC | 222 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 214 |
| Convertors | Cardinal Health 200, LLC | 184 |
| Lac-Mac | LAC-MAC Limited | 157 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 126 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 107 |
| ComPel Surgical Gown | Standard Textile Co., Inc. | 67 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 55 |
| ComPel MLR Surgical Gown | Standard Textile Co., Inc. | 38 |
| Medline Industries, Inc. | Medline Industries, Inc. | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141095 | 2014-08-26 |
| K121664 | 2014-03-10 |
| K040764 | 2004-04-27 |
| K944393 | 1995-08-28 |
Recalls
29 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34,570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | 34570 total products | 2019-05-23 |
| 2014-12-22 | Class III | Error in labeling | A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01. | 1530 units (170 cases) | 2015-05-05 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 21,660 units (2166 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 9,930 units (993 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 2,980 units (298 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 34,640 units (3,464 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 1,980 units (198 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 2,000 units ( 200 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 7960 units (796 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 88,040 units (8,804 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 3000 units (300 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 48,040 units, ( 4804 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 334,520 units (33,452 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 3,000 units (300 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 5,000 units ( 500 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 25,770 units (2,577 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 3,980 units ( 398 boxes) | 2014-04-14 |
| 2013-05-23 | Class II | Nonconforming Material/Component | Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year o | 6,990 units ( 699 boxes) | 2014-04-14 |
| 2012-06-01 | Class II | Process control | The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaint | 23,653 ( past 3 years) 47937 all years | 2014-04-14 |
| 2012-06-01 | Class II | Process control | The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaint | 16, 846 (last 3 years) 35,492 all years | 2014-04-14 |
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.