(567 days)
Not Found
No
The device is a disposable surgical gown, and the description focuses on its material composition, barrier performance, and sterilization process. There is no mention of any computational or analytical functions that would involve AI/ML.
No
The device, a surgical gown, is intended for protection from microorganisms, body fluids, and particulate material, not for treating or diagnosing a disease or condition.
No
This device is a surgical gown, which is a protective apparel. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly states it is a physical surgical gown made of various fabric layers and components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description details the materials and construction of a surgical gown, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue), detect biomarkers, or provide any kind of diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties (tensile strength, tear strength, seam strength, water resistance, flammability, lint) and biocompatibility (cytotoxicity, sensitization, irritation, EO residuals). These are relevant to a protective barrier device, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room persomel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical gowns met the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.
The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.
The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject surgical gown was assessed for performance using the following Standards and Test Methods:
- ASTM D5034-09 for Tensile Testing: Head To Toe Peak Load (N) AVG was 138.8N, Cross Body AVG was 95.6N. Pass.
- ASTM D5733 for Tearing Strength of Fabrics by Trapezoid Procedure: HEAD TO TOE AVG was 57.3N, CROSS BODY AVG was 37.5N. Pass.
- ASTM D1683 for Seam Strength: Min 59.0N. Pass.
- AATCC 42 for Water Resistance: Spray Impact Water:
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
October 28, 2022
Xiantao Rhycom Non-woven Products Co., Ltd % Jet Li Regulation Manager PureVision Ai, Inc. Contact Address
Re: K211060
Trade/Device Name: Disposable Surgical Gown Rk-3011C Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: October 26, 2022 Received: October 27, 2022
Dear Jet Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Disposable Surgical Gown (Rk-3011C)
Indications for Use (Describe)
The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.
This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K211060
510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 870.92. This summary was prepared on October 17, 2022.
Submitter Information 1.
Sponsor Company Name: Xiantao Rhycom Non-woven Products Co., Ltd Address: Chuangye Road, Longhuashan Sub-district, Xiantao City, Hubei, China Phone: 86-15271157850 Contact Person (including title): Liu Yang (Operational position) E-mail: Yang@chinarhycom.com
Application Correspondent: PureVision Ai, Inc. Address: 111 Town Square Place Suite 1203, Jersey City, NJ, 07310-2784, USA Contact:
Name: Mr. Bryan Wong Title: Associate
Tel: +1 201-371-3083 Email: bryan@purefda.com
Alternate Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-18588874857 Email: jet@ne.purefda.com
2. Subject Device Information
- � Type of 510(k) submission: Traditional
- Classification/Common Name: Surgical Gown, Surgical Apparel �
- � Trade Name: Disposable Surgical Gown Rk-3011C
- Model: Rk-3011C �
- Review Panel: General & Plastic Surgery �
- Product Code: FYA �
- Regulation Number: 21 CFR 878.4040 �
- Regulation Class: Class II �
K211060 Page 1 of 6
4
Predicate Device Information 3.
- � 510(k) number: K172987
- � Sponsor: Wuhan Dymex Healthcare Co., Ltd.
- Classification/Common Name: Surgical Gown, Surgical Apparel �
- Trade Name: Surgical Gown (AG1001, AG2001, AG3001) �
- Model: AG1001, AG2001, AG3001 �
- � Review Panel: General & Plastic Surgery
- Product Code: FYA �
- � Regulation Number: 21 CFR 878.4040
- Regulation Class: Class II �
4. Device Description
The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.
The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.
The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.
Intended Use/Indications for Use 5.
The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room persomel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical gowns met the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
5
6. Comparison of technological characteristics with the predicate
The primary components of The Disposable Surgical Gown Rk-3011C are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicate devices.
| Element of Comparison | Subject Device (K211060) | Predicate Device (K172987) | Comparison |
|---|---|---|---|
| 510(K) | K211060 | K172987 | -- |
| Product Name | Disposable Surgical Gown Rk- | ||
| 3011C | Surgical Gown (AG1001, AG2001, | ||
| AG3001) | -- | ||
| Classification | Class II, FYA (21 CFR878.4040) | Class II, FYA (21 CFR878.4040) | Same |
| Intended Use/Indications for Use | Surgical gown is intended to be | ||
| worn by operating room personnel | |||
| during surgical procedure to protect | |||
| both the surgical patient and the | |||
| operating room personnel from | |||
| transfer of microorganisms, body | |||
| fluids, and particulate material. | |||
| Per ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in health | |||
| care facilities, the Rk-3011C | |||
| surgical gowns met the requirements | |||
| for Level 3 classification. | |||
| The Surgical Gown is single use, | |||
| disposable medical device provided | |||
| non-sterile. The Surgical Gowns is | |||
| to be sold to re-packager/re-labeler | |||
| establishments for ethylene oxide | |||
| (EtO) sterilization according to ISO | |||
| 11135 prior to marketing to the end | |||
| user. | Surgical gown is intended to be worn | ||
| by operating room personnel during | |||
| surgical procedure to protect both the | |||
| surgical patient and the operating | |||
| room personnel | |||
| from transfer of | |||
| microorganisms, | |||
| body | |||
| fluids, and | |||
| particulate material. | |||
| Per ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and classification | |||
| of protective apparel and drapes | |||
| intended for use in health care | |||
| facilities, the AG series surgical | |||
| gowns met the requirements for Level | |||
| 3 classification. | Same. | ||
| Additional | |||
| statement | |||
| added to | |||
| intended use | |||
| of Subject | |||
| Device meets | |||
| current | |||
| requirements | |||
| for FDA. | |||
| Style | Poly-reinforced | Non-reinforced/Fabric- | |
| reinforced/Poly-reinforced | Similar. | ||
| Differences | |||
| addressed by | |||
| performance | |||
| testing. No | |||
| new issues of | |||
| safety or | |||
| effectiveness. | |||
| Size | M, L, XL, XXL | XL | No new issues |
| of safety or | |||
| effectiveness. | |||
| Color | Blue | Blue | Same |
| Durability | Disposable | Disposable | Same |
| Sterile | Sterile by packager | Sterile by packager | Same |
| Sterilization Method | EO | EO | Same |
| Ethylene oxide residuals | EO30N | >30N | Same |
| Fire | |||
| protection | Class I | Class I | Class I |
| Lint | Log1030N | ≥20N | |
| comply | |||
| Seam | |||
| Strength | ≥30N | Min 59.0N | Not disclosed |
| comply | |||
| Durability | Disposable | Disposable |
Table 3 Biocompatibility Comparison
| Element of Comparison | Subject Device (K211060) | Predicate Device (K172987) | Comparison |
|---|---|---|---|
| Material | SMMS, Microporous and | ||
| polypropylene | SMMMS, Polypropylene, PE (Poly | ||
| Ethylene), Polyester | Similar. | ||
| Differences | |||
| addressed by | |||
| performance | |||
| testing. No | |||
| new issues of | |||
| safety or | |||
| effectiveness | |||
| Biocompatibility | Under the conditions of the study, | ||
| the device is non-cytotoxic, non- | |||
| irritating, and non-sensitizing | Under the conditions of the study, the | ||
| device is non-cytotoxic, non-irritating, | |||
| and | |||
| non-sensitizing | Same |
7
7. Discussion of Non-Clinical Tests Performed:
The subject surgical gown was assessed for performance using the following Standards and Test Methods
| Test Methodology | Test
Methodology
Purpose | Acceptance
Criteria | Test Results | Pass/Fail |
|----------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| ASTM D5034-09 | Tensile Testing | ≥30N | Head To Toe Peak Load (N)
AVG was 138.8N, Cross Body
AVG was 95.6N | Pass |
| ASTM D5733 | Tearing Strength
of
Fabrics by
Trapezoid
Procedure | ≥10N | HEAD TO TOE AVG was 57.3N,
CROSS BODY AVG was 37.5N. | Pass |
| ASTM D1683 | Seam Strength | ≥30N | Min 59.0N | Pass |
| AATCC 42 | Water
Resistance:
Spray Impact
Water |