(76 days)
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene.
The provided text is for a 510(k) premarket notification for Sterile Polyisoprene Powder Free Surgical Gloves and details the device's technical characteristics and substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested categories for AI/medical imaging studies are not applicable.
However, I can extract the acceptance criteria and the device's reported performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristics | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (Result Summary) |
|---|---|---|
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577 requirements for length, width and thickness |
| - Length | Minimum 265mm | Average 305mm |
| - Palm Width (size 5½) | 70mm | 73mm |
| - Palm Width (size 6) | 76mm | 79mm |
| - Palm Width (size 6½) | 83mm | 86mm |
| - Palm Width (size 7) | 89mm | 91mm |
| - Palm Width (size 7½) | 95mm | 97mm |
| - Palm Width (size 8) | 102mm | 105mm |
| - Palm Width (size 8½) | 108mm | 111mm |
| - Palm Width (size 9) | 114mm | 117mm |
| - Thickness (Finger) | Minimum 0.10mm | 0.22mm |
| - Thickness (Palm) | Minimum 0.10mm | 0.20mm |
| - Thickness (Cuff) | Minimum 0.10mm | 0.18mm |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging |
| - Tensile Strength, Before Aging | 17MPa, min | Average 19.4MPa |
| - Ultimate Elongation, Before Aging | 650%, min | Average 823% |
| - Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa |
| - Tensile Strength, After Accelerated Aging | 12MPa, min | Average 17.1 MPa |
| - Ultimate Elongation, After Accelerated Aging | 490%, min | Average 748% |
| Freedom from holes | ASTM D3577-09(2015) and ASTM D5151-06(2015) requirements of AQL 1.5 | Meets ASTM D3577-09(2015) and ASTMD5151-06(2015) requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09(2015) and ASTM D6124-06(2011) - ≤ 2 mg per glove | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Under the conditions of the study, not an irritant |
| Biocompatibility (Maximization Sensitization) | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
Regarding the other requested information (primarily for AI/medical imaging studies):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for physical and biological properties of surgical gloves, not an AI model. The tests refer to ASTM and ISO standards, which define the testing methodologies and sample sizes for those specific tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/medical imaging (e.g., expert consensus on image findings) is not relevant here. The "ground truth" for the glove's performance is adherence to established engineering and biocompatibility standards.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert reviewers, which is not relevant for this type of device testing.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the objective performance specified in the referenced ASTM and ISO standards (e.g., a specific tensile strength value, freedom from holes at a certain AQL).
- 8. The sample size for the training set: Not applicable. This is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
Key takeaway from the document: The device demonstrates compliance with recognized national and international standards (ASTM and ISO) for surgical gloves. The "study" proving the device meets the acceptance criteria consists of various material, physical, and biological tests conducted according to these standards, with the results compared directly to the specified requirements within those standards. A clinical study was explicitly stated as not conducted for either the subject or predicate devices.
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Public Health Service
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June 22, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc 2235 E Francis St Ontario. California 91761
Re: K171047
Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: May 17, 2017 Received: May 17, 2017
Dear Kathy Liu:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark S. Fellman -S
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171047
Device Name
Sterile Polyisoprene Powder Free Surgical Gloves
Indications for Use (Describe)
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating to protect a surgical wound from contamination.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR 807.92.
The assigned 510(K) numbers: K171047
1. Owner's Identification:
Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Tel:86-311-83601854 Fax: 86-311-83616934
Contact: Ms. Kathy Liu, Project Manager Address: 2235 E Francis St, Ontario CA 91761 Tel:909-590-1611 Fax: 909-673-8347
Date Summary Prepared: March 23, 2017
2. Name of the Device:
Trade Name: Sterile Polyisoprene Powder Free Surgical Gloves Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves Classification Regulation:21 CFR 878.4460 Product Code: KGO Classification Panel: General and Plastic Surgery Device Class: Class I
3. Predicate Device Information:
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210, Iselin, NJ 08830 USA Gammex PI Hybrid Surgical Glove (also marketed as Encore PI HybridSurgical Glove) (K 151694)
4. Device Description:
The subject device is single-use disposable powder-free surgical glove that is supplied
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
sterile and made of polyisoprene.
5. Intended for Use:
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
6. Technological Characteristics:
Sterile Polyisoprene Powder Free Surgical Gloves have the following technological characteristics as compared to ASTM or equivalent standards:
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D3577-09(2015) | Meets ASTM D3577requirements for length, widthand thickness |
| --Length | Minimum 265mm | Average 305mm |
| --Palm Width (size) | (mm) | Average value in mm |
| 5½ | 70ଖ | 73 |
| 6 | 76ଖ | 79 |
| 6½ | 83ଖ | 86 |
| 7 | 89ଖ | 91 |
| 7½ | 95ଖ | 97 |
| 8 | 102ଖ | 105 |
| 8½ | 108ଖ | 111 |
| 9 | 114ଖ | 117 |
| --Thickness | Average value in mm | |
| Finger | Minimum 0.10 | 0.22 |
| Palm | Minimum 0.10 | 0.20 |
| Cuff | Minimum 0.10 | 0.18 |
| Physical Properties | ASTM D3577-09(2015) | Meets ASTM D3577-09(2015)requirements for tensile strengthand elongation at break beforeand after accelerated aging |
| Tensile Strength, BeforeAging | 17MPa, min | Average 19.4MPa |
| Ultimate Elongation, BeforeAging | 650%, min | Average 823% |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa |
| Tensile Strength, AfterAccelerated Aging | 12MPa, min | Average 17.1 MPa |
| Ultimate Elongation, AfterAccelerated Aging | 490%, min | Average 748 % |
| Freedom from holes | ASTM D3577-09(2015) | Meets ASTM D3577-09 (2015) |
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Fuqian Xi Road, West district of Shenze Industrial Base,
| ASTM D 5151-06(2015) | and ASTMD5151-06(2015)requirements of AQL1.5 | |
|---|---|---|
| Powder-Free | ASTM D3577-09(2015)ASTM D 6124-06(2011) | Meets Applicable requirement forPowder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility | ||
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the study,not an irritant |
| ISO MaximizationSensitization Study | ISO 10993-10:2010 | Under the conditions of the study,not a sensitizer |
7. Substantial Equivalence:
| Substantial Equivalence Comparison Table | |||
|---|---|---|---|
| Predicate | Subject Device | Comparison | |
| Device Class | Class I | Class I | Same |
| 510K | K151694 | K171047 | Same |
| Product Code | KGO | KGO | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulation Name | Surgeon's | Surgeon's | Same |
| Indications for Use | This glove is intended tobe worn by operatingroom personnel to protecta surgical wound fromcontamination. | This surgeon's glove is asterile and single use deviceintended to be worn on thehands of operating roompersonnel to protect asurgical wound fromcontamination | Same |
| Prescription | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic rubber blend ofpolyisoprene andneoprene | Synthetic polyisoprenerubber | Different |
| Design | Single use | Single use | Same |
| Sterile | Sterile | Sterile | Same |
| Powder-free | Powder-free | Powder-free | Same |
| Hand specific | Hand specific | Hand specific | Same |
| Beaded cuff | Beaded cuff | Beaded cuff | Same |
| Color | White | Clear | Different |
| Sterilization Method | Radiation | Radiation | Same |
| Sterility Assurance Level(SAL) | 10-6SAL | 10-6SAL | Same |
| Shelf Life | 3 years | 3 years | Same |
| Dimensions and physical | Meets ASTM D3577-09/2015)requirements | Meets ASTM D3577-09/2015)requirements | Same |
| properties |
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| Freedom from holes | Meets ASTM D3577-09(2015)requirements of | Meets ASTM D3577-09(2015)requirements of | Same |
|---|---|---|---|
| -------------------- | ---------------------------------------------- | ---------------------------------------------- | ------ |
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
| AQL 1.5 | AQL 1.5 | ||
|---|---|---|---|
| Powder-Free | Meets ApplicableDefinition for PowderFree; ≤ 2 mg per glove | Meets ApplicableDefinition for PowderFree; ≤ 2 mg per glove | |
| Biocompatibility | "Under the conditions ofthe study, not an irritant"and "Under theconditions of the study,not a sensitizer" | "Under the conditions ofthe study, not an irritant"and "Under the conditionsof the study, not asensitizer" |
The subject device is manufactured from Synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from Synthetic rubber blend of polyisoprene and neoprene with polyurethane polymer inner coating to aid donning. Though the materials of construction differ, the subject device's materials are functionally equivalent to those of the cited predicate.
The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577-09(2015), ASTM D5151-06(2015) and ASTM D6124-06(2011). The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
8. Performance Data
A clinical study was not conducted on the subject or predicate devices.
9. Conclusion:
Based on the performed nonclinical test results, the Sterile Polyisoprene Powder Free Surgical Gloves is as safe, as effective, and performs as well as or better than the legally marketed device identified as Gammex PI Hybrid Surgical Glove, which was previously cleared under K151694, Class I (21 CFR 878.4460, Product code KGO).
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).