Disposable Surgical Gown Rk-3011C
Device Facts
| Record ID | K211060 |
|---|---|
| Device Name | Disposable Surgical Gown Rk-3011C |
| Applicant | Xiantao Rhycom Non-Woven Products Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Oct 28, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Disposable surgical gown (Rk-3011C) provides barrier protection for operating room personnel and patients. Four-layer construction (spun-bond/melt-blown polypropylene) with microporous reinforcement; back-open design with ties; cotton/terylene cuffs. Provided non-sterile to re-packagers for ethylene oxide sterilization. Used in surgical settings to prevent cross-contamination of fluids and particulates. Performance verified via bench testing against AAMI PB70 Level 3 standards. No clinical data required.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM D5034-09 (tensile), ASTM D5733 (tear), ASTM D1683 (seam), AATCC 42 (spray impact), AATCC 127/ANSI/AAMI PB70:2012/ISO 811:2018 (hydrostatic pressure), ISO 9073-10:2003 (lint), 16 CFR 1610 (flammability), and ISO 10993 series (biocompatibility/EO residuals).
Technological Characteristics
Four-layer polypropylene (spun-bond/melt-blown) with microporous reinforcement. Cuffs: cotton/terylene. Barrier: AAMI PB70 Level 3. Sterilization: Ethylene Oxide (ISO 11135). Biocompatibility: ISO 10993 compliant. Sizes: M, L, XL, XXL.
Indications for Use
Indicated for operating room personnel during surgical procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate material. Level 3 barrier protection per ANSI/AAMI PB70:2012.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Surgical Gown (AG1001, AG2001, AG3001) (K172987)
Submission Summary (Full Text)
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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
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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
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# Indications for Use
Submission Number (if known)
K211060
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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## 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
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### 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.
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### 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-<br>3011C | Surgical Gown (AG1001, AG2001,<br>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<br>worn by operating room personnel<br>during surgical procedure to protect<br>both the surgical patient and the<br>operating room personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material.<br>Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and<br>classification of protective apparel<br>and drapes intended for use in health<br>care facilities, the Rk-3011C<br>surgical gowns met the requirements<br>for Level 3 classification.<br>The Surgical Gown is single use,<br>disposable medical device provided<br>non-sterile. The Surgical Gowns is<br>to be sold to re-packager/re-labeler<br>establishments for ethylene oxide<br>(EtO) sterilization according to ISO<br>11135 prior to marketing to the end<br>user. | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating<br>room personnel<br>from transfer of<br>microorganisms,<br>body<br>fluids, and<br>particulate material.<br>Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, the AG series surgical<br>gowns met the requirements for Level<br>3 classification. | Same.<br>Additional<br>statement<br>added to<br>intended use<br>of Subject<br>Device meets<br>current<br>requirements<br>for FDA. |
| Style | Poly-reinforced | Non-reinforced/Fabric-<br>reinforced/Poly-reinforced | Similar.<br>Differences<br>addressed by<br>performance<br>testing. No<br>new issues of<br>safety or<br>effectiveness. |
| Size | M, L, XL, XXL | XL | No new issues<br>of safety or<br>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 | EO< 4 mg/device;<br>ECH <9 mg/device<br>Met requirements of ISO 10993-7:2008 | Data not available, required to meet the<br>requirements of ISO 10993-7: 2008 | Same |
# Table 1 General Comparison
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Table 2 Performance Characteristic Comparison
| Element of<br>Comparison | Test results<br>/Verdict | Subject Device (K211060) | Predicate Device (K172987) | Comparison | |
|------------------------------|--------------------------------|-----------------------------------------------------------------------------|----------------------------|----------------------------------|------------------------------------------------------------------------|
| | | | | | |
| Physical<br>Specification | Barrier<br>protection<br>level | Level 3 | Level 3 per AAMI PB70 | Level 2/Level 3 per AAMI<br>PB70 | Subject device<br>provides<br>higher level of<br>barrier<br>protection |
| | Tearing<br>Strength | ≥10N | >30N | >30N | Same |
| | Fire<br>protection | Class I | Class I | Class I | Same |
| | Lint | Log10<4 | Log10=2.53 | Log10<4 | Same |
| Mechanical<br>Specifications | Tensile<br>Strength | Head To Toe Peak<br>Load (N)<br>AVG was 138.8N, Cross<br>Body AVG was 95.6N | >30N | ≥20N | Same, both<br>comply |
| | Seam<br>Strength | ≥30N | Min 59.0N | Not disclosed | Same, both<br>comply |
| | Durability | Disposable | Disposable | Disposable | Same |
Table 3 Biocompatibility Comparison
| Element of Comparison | Subject Device (K211060) | Predicate Device (K172987) | Comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Material | SMMS, Microporous and<br>polypropylene | SMMMS, Polypropylene, PE (Poly<br>Ethylene), Polyester | Similar.<br>Differences<br>addressed by<br>performance<br>testing. No<br>new issues of<br>safety or<br>effectiveness |
| Biocompatibility | Under the conditions of the study,<br>the device is non-cytotoxic, non-<br>irritating, and non-sensitizing | Under the conditions of the study, the<br>device is non-cytotoxic, non-irritating,<br>and<br>non-sensitizing | Same |
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# 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<br>Methodology<br>Purpose | Acceptance<br>Criteria | Test Results | Pass/Fail |
|----------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| ASTM D5034-09 | Tensile Testing | ≥30N | Head To Toe Peak Load (N)<br>AVG was 138.8N, Cross Body<br>AVG was 95.6N | Pass |
| ASTM D5733 | Tearing Strength<br>of<br>Fabrics by<br>Trapezoid<br>Procedure | ≥10N | HEAD TO TOE AVG was 57.3N,<br>CROSS BODY AVG was 37.5N. | Pass |
| ASTM D1683 | Seam Strength | ≥30N | Min 59.0N | Pass |
| AATCC 42 | Water<br>Resistance:<br>Spray Impact<br>Water | <0.1 g | <0.1 g | Pass |
| AATCC<br>127,ANSI/AAMI<br>PB70:2012, and ISO<br>811:2018 | Resistance:<br>Hydrostatic<br>Pressure | ≥50 cm H2O | 50cmH2O ≤ Chest: < 162cmH2O<br>50cmH2O ≤ Sleeve: <114cmH2O<br>50cmH2O ≤ Sleeve Seam: <<br>95.1cmH2O | Pass |
| ISO 9073-10:2003 | Determining<br>Lint | <4 | <4 | Pass |
| 16 CFR 1610 | Flammability | Class I | Class I | Pass |
| ISO 10993-5: 2009 | In Vitro<br>Cytotoxicity | Under the condition of<br>the test, the test article<br>must be non-cytotoxic | Under the condition of the test,<br>the test article was found to be<br>non-cytotoxic | Pass |
| ISO 10993 -10: 2010 | Skin<br>Sensitization | Under the condition of<br>the test, the test article<br>must be non-sensitizing | Under the condition of the test,<br>the test article was found to be<br>non-sensitizing | Pass |
| ISO 10993 -10: 2010 | Skin Irritation<br>test | Under the conditions of<br>the test, the test article<br>must be non-irritating | Under the conditions of the test,<br>the test article was found to be<br>non-irritating | Pass |
| ISO 10993-7: 2008 | Ethylene Oxide<br>(EO)/ Ethylene<br>Chlorohydrin<br>(ECH) Residuals | Under the conditions of<br>the test, the test article<br>must meet with EO and<br>ECH residual limit:<br>EO< 4 mg/device;<br>ECH <9 mg/device | Under the conditions of the study,<br>the test article meets the<br>allowable limits of Ethylene<br>Oxide (EO) and Ethylene<br>Chlorohydrin (ECH) | Pass |
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### Summary of Clinical Test 8.
Clinical testing is not needed for the subject devices.
### 9. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device, the Disposable Surgical Gown Rk-3011C, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Surgical Gown cleared under K172987.
