(212 days)
Not Found
No
The device is a surgical gown, and the description focuses on its material properties and physical construction, with no mention of software, algorithms, or data processing.
No.
The device is a surgical gown intended to protect patients and personnel from the transfer of microorganisms and fluids, not to treat or diagnose a medical condition.
No
This device is a surgical gown, intended to protect patients and personnel from the transfer of microorganisms and fluids. It does not diagnose any medical condition.
No
The device is a physical surgical gown made of fabric, not software. The summary describes material properties and physical testing.
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 personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and construction of the gown (materials, seams, barrier performance). There is no mention of any components or functions related to analyzing samples from the human body.
- Performance Studies: The performance studies listed are all related to the physical and biological safety of the gown as a barrier (tensile strength, tear strength, linting, water resistance, flame spread, cytotoxicity, sensitization, irritation, sterilization residue, seal integrity, aging). None of these are diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This surgical gown does not fit that definition.
N/A
Intended Use / Indications for Use
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
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
Used in healthcare facilities.
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)
Non-Clinical Testing:
- ASTM F2407-20, Section 7.2 Tensile Strength ASTM D5034-09(R17): Evaluated tensile strength of gown material. Criteria: >= 30N. Result: Pass.
- ASTM F2407-20, Section 7.2 Seam Strength ASTM D1683/D1683M-22: Evaluated tensile strength of gown seam. Criteria: >= 30N. Result: Pass.
- ASTM F2407-20, Section 7.2 Tearing Strength ASTM D5733-99: Evaluated tear strength of gown material. Criteria: >= 10N. Result: Pass.
- ASTM F2407-20, Section 7.3 Lint Generation ISO 9073-10:2003: Evaluated potential for linting. Criteria: Documentation only. Result: Pass.
- ASTM F2407-20, Section 7.3 Evaporative Resistance ASTM F1868-17: Evaluated evaporative resistance. Criteria: Documentation only. Result: Pass.
- Water Resistance: Hydrostatic Pressure AATCC 42:2017: Evaluated hydrostatic water resistance. Criteria: >= 50cmH20. Result: Pass.
- Water Resistance: Impact Penetration AATCC 127:2018e: Evaluated water spray resistance. Criteria: 50 cmH₂O, Sleeve Seam: > 50 cmH2O, Tie attachment with/without film: > 50 cmH₂O
Water Resistance: Impact Penetration: Base material: 0 g, Sleeve Seam: 0 g, Tie attachment with/without film: 0 g
All biocompatibility tests (Cytotoxicity, Sensitization, Primary Skin Irritation) showed no adverse effects.
Sterility Assurance Level: 10-6
Sterilant Residuals: EO:
§ 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.
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October 12, 2023
Skypro Medical Supplies Company Cyrus Wong General Manager C301, Tsing Yi Industrial Centre Phase 2. 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong. China
Re: K230707
Trade/Device Name: Skypro, Surgical Gown 6021 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 14, 2023 Received: September 14, 2023
Dear Cyrus Wong:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Bifeng Qian -S" in a simple, sans-serif font. The text is arranged horizontally, with "Bifeng" and "Qian" being the most prominent words. The "-S" is smaller and slightly offset to the right. The background is plain white.
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
3
Indications for Use
510(k) Number (if known) K230707
Device Name Skypro, Surgical Gown 6021
Indications for Use (Describe)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
| 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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4
510(k) Summary K230707
This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92.
l. Submitter
Company: Skypro Medical Supplies Company Address: Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong, P. R. China Contact Person: Cyrus Wong (General Manager) Phone No.: 852-27110882 Fax No.: 852-27110116 Email: cyrus@skypro-med.com Date Prepared: October 12, 2023
US Agent and Correspondent of the Submitter: Company: SKYPRO MEDICAL SUPPLIES USA LTD COMPANY Address: 5722 Kendall Hill Ln, Sugar Land, TX 77479 Contact Person: Eve Luo Email: Eve@1masks.com Phone No.: 832-312-2668 EIN/TAX ID: 851587593
II. Device
Device Manufacturer: SPRO Medical Products (Xiamen) Co., Ltd Address: No.139 Factory Building, TongAn Garden, TongAn Industrial Area, Xiamen, Fujian Province, 361100, P. R. China Device Trade Name: Skypro, Surgical Gown 6021 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown
III. Predicate Device
K162442 This predicate has not been subject to a design-related recall. Device Trade Name: ComfortGuard Surgical Gown, i500 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown
IV. Device Description
1
5
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
V. Indications for Use/ Intended Use
"Skypro, Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single-use, disposable, and provided sterile.
| Description | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| K162442 | |||
| "ComfortGuard Surgical | |||
| Gown, i500" | K230707 | ||
| "Skypro, Surgical Gown 6021" | |||
| Indications for Use | ComfortGuard Surgical | ||
| Gown, i500 are single use | |||
| surgical gowns intended to | |||
| protect surgical patients | |||
| and operating room | |||
| personnel from the | |||
| transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. | |||
| ComfortGuard Surgical | |||
| Gown, i500 have been | |||
| tested and are classified as | |||
| Level 3 in the critical zones | |||
| per AAMI Standard PB70 | |||
| Liquid barrier performance | |||
| and classification of | |||
| protective apparel and | |||
| drapes intended for use in | |||
| healthcare facilities. | "Skypro, Surgical Gown 6021" | ||
| are intended to protect both | |||
| surgical patients and operating | |||
| room personnel from the | |||
| transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. They are classified as | |||
| Level 3 surgical gowns in | |||
| accordance with ANSI/AAMI | |||
| PB70 and used in healthcare | |||
| facilities. The gown is single- | |||
| use, disposable, and provided | |||
| sterile. | Similar | ||
| Design | Neck binder, hook-and- | ||
| loop neck closures. belt | Raglan sleeves, hook-and-loop | ||
| neck closures. and tie waist | Same | ||
| ties, removable transfer | |||
| accessory, and cuffs. | closures | ||
| Material | Single-layer nonwoven | ||
| SMS polyolefin fabrics | |||
| throughout the entire | |||
| gown, with no additional | |||
| reinforcement | Non-woven SMS polypropylene | ||
| fabrics throughout the entire | |||
| gown, with no additional | |||
| reinforcement | Same | ||
| Color | Blue | Blue | Same |
| Performance Characteristics | |||
| AAMI PB 70 | |||
| Classification | Level 3 | Level 3 | Same |
| Tensile Strength | |||
| (ASTM D5034 or | |||
| ASTM D5035) | Body/sleeve material: |
- MD: 82.8 N
- CD: 58.54 N
Back material: - MD: 89.52 N
- CD: 56.32 N | Warp yarns torn (MD): 179.7 N
Weft yarns torn (CD): 103.7 N | Similar |
| Seam Strength
(ASTM
D16836/D1683M-17) | Sleeve seam: ≥ 15 N
Armhole seam:
Experimental data are not
available
Shoulder seam:
Experimental data are not
available | Sleeve seam: 113.3 N
Armhole seam: 73.2 N
Shoulder seam: 111.1 N | Different
Data is not
available for
the predicate
device. Data
demonstrates
subject device
complies with
ASTM F2407. |
| Tearing Strength
(ASTM D5587) | Body/sleeve material - MD:19.01 N
- CD: 28.14 N
Back material - MD: 21.19 N
- CD: 37.00 N | Warp yarns torn (MD): 53.9 N
Weft yarns torn (CD): 29.2 N | Similar |
| Lint Generation
(ISO 9073-10) | Not stated | Side A (face):
Total linting: 140.9
Coefficient of linting: 2.15
Side B (back):
Total linting: 242.2
Coefficient of linting: 2.38 | Different
Data is not
available for
the predicate
device. |
| Evaporative
Resistance (ASTM
F1868-17) | Not stated | 0.00215 kPa·m²/W | Different
Data is not
available for
the predicate
device. |
| Water Resistance:
Hydrostatic Pressure
(AATCC 127 and
ANSI/AAMI PB70) | Base material: 657 mmH2O
Sleeve seam: 760 mmH2O
Tie attachments: 668
mmH₂O | Base material: > 50 cmH₂O
Sleeve Seam: > 50 cmH2O
Tie attachment with/without
film: > 50 cmH₂O | Similar |
| Water Resistance:
Impact Penetration
(AATCC 42 and
ANSI/AAMI PB70) | Base material: 0.04 g
Sleeve seam: 0.04 g
Tie attachments: 0.02 g
No penetration can be
observed | Base material: 0 g
Sleeve Seam: 0 g
Tie attachment with/without
film: 0 g
No penetration can be
observed | Similar |
| Flammability Class 16
CFR Part 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under conditions of the
testing, non-cytotoxic | Under conditions of the testing,
non-cytotoxic | Same |
| Sensitization | Under conditions of the
testing, not a sensitizer | Under conditions of the testing,
not a sensitizer | Same |
| Primary Skin
Irritation | Under conditions of the
testing, not an irritant | Under conditions of the testing,
not an irritant | Same |
| Sterility and Shelf Life | | | |
| Sterilization | Sterile; single-use | Sterile; single-use | Same |
| Sterility Assurance
Level | Not stated | 10-6 | Different
Data is not
available for
predicate
device. Data
demonstrates
subject device
has
acceptable
sterility
assurance
level. |
| Sterilization modality | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilant Residuals | Not stated | EO: