(53 days)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
The following chemicals have been tested with these gloves.
The tested chemotherapy drugs' breakthrough detection times are listed as follows:
Chemotherapy Drug Minimum BDT
Carmustine, 3.3 mg/ml 16.0 min.
Cisplatin, 1.0 mg/ml >240 min.
Cyclophosphamide (Cytoxan) , 20 mg/ml >240 min.
Doxorubicin Hydrochloride, 2.0 mg/ml >240 min.
Etoposide (Toposar) , 20.0 mg/ml >240 min.
Fluorouracil, 50.0 mg/ml >240 min.
Methotrexate, 25 mg/ml >240 min.
Paclitaxel (Taxol) , 6.0 mg/ml >240 min.
Thiotepa, 10.0 mg/ml 16.6 min.
Vincristine Sulfate, 1.0 mg/ml >>240 min
Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes. WARNING: Do not use with Carmustine and Thio-Tepa.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
The provided document describes the acceptance criteria and performance data for "Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs" (K171898) compared to a predicate device, "SensiCare PI Surgical Glove" (K152428).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Predicate Device K152428 & ASTM Standards) | Reported Device Performance (Subject Device K171898) |
|---|---|---|
| Physical Properties | ||
| Dimensions - Length | Meets ASTM D3577: 270mm min. | Similar |
| Dimensions - Width | Meets ASTM D3577: 5 1/2-70±6mm, 6-76±6mm, 6 1/2-83±6mm, 7-89±6mm, 7 1/2-95±6mm, 8-102±6mm, 8 1/2-108±6mm, 9-114±6mm | Similar |
| Dimensions - Finger Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Palm Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Cuff Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Before Aging - Tensile Strength | Meets ASTM D3577: 17 MPa min | Similar |
| Before Aging - Ultimate Elongation | Meets ASTM D3577: 650% min | Similar |
| Before Aging - Stress at 500% Elongation | Meets ASTM D3577: 7.0 MPa min | Similar |
| After Aging - Tensile Strength | Meets ASTM D3577: 12 MPa min | Similar |
| After Aging - Ultimate Elongation | Meets ASTM D3577: 490% min | Similar |
| Integrity | ||
| Freedom from holes | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151: Inspection Level 1, AQL 1.5 | Similar |
| Powder-Free - Residual Powder | <2mg of residual powder when tested in accordance with ASTM D3577 | Similar |
| Sterility Assurance Level (SAL) | 10⁻⁶ SAL | 10⁻⁶ SAL |
| Biocompatibility | ||
| Sensitization/Irritation | "Under the conditions of the study, not an irritant" and "Under the conditions of the study, not a sensitizer" (ISO 10993 series) | "Under the conditions of the study, not an irritant" and "Under the conditions of the study, not a sensitizer" |
| Chemotherapy Drug Permeation (ASTM D6978) | ||
| Carmustine, 3.3 mg/ml | 10.1 min (predicate) | 16.0 min |
| Cisplatin, 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan), 20 mg/ml | >240 min | >240 min |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 min | >240 min |
| Etoposide (Toposar), 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil, 50.0 mg/ml | >240 min | >240 min |
| Methotrexate, 25 mg/ml | >240 min | >240 min |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 min | >240 min |
| Thiotepa, 10.0 mg/ml | 11.6 min (predicate) | 16.6 min |
| Vincristine Sulfate, 1.0 mg/ml | >240 min | >240 min |
| Other Chemotherapy Drugs (e.g., Cytarabine, etc.)* | >240 min (for predicate, not explicitly tested for subject device in this summary) | Not explicitly stated for subject device in this summary (but overall conclusion states similarity) |
*Note: The subject device's comparison table explicitly lists only 10 chemotherapy drugs, while the predicate device listing includes an additional 5. However, the overall conclusion of substantial equivalence implies the subject device performs similarly across all relevant criteria that define the predicate. The document states a general conclusion that "The nonclinical testing performed... demonstrates that this device is as safe, as effective, and performs as well as the predicate device".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for physical properties, number of permeation tests for each chemotherapy drug).
- Test Set Sample Size: Not explicitly stated for each test.
- Data Provenance: The physical and chemical permeation testing would be conducted in a laboratory setting based on the specified ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd., is located in China, suggesting the testing was likely conducted by or for them, potentially in China or a qualified testing facility. The data appears to be prospective as it was generated to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device. The "ground truth" for surgical gloves and chemotherapy drug permeation is established through validated, standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus or clinical assessment in the same way an AI diagnostic imaging device would have. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For laboratory performance testing of physical properties and chemical resistance, the results are quantitative measurements against predefined criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. A MRMC comparative effectiveness study is not applicable to this type of medical device. This is a study design used for diagnostic devices, particularly in imaging, to assess reader performance with and without AI assistance. This document describes laboratory performance testing of a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an algorithm or AI device. It's a physical medical device (surgical gloves). The performance tested relates to its physical and chemical barrier properties in a standalone manner (i.e., the glove itself, not with human interaction beyond wearing it).
7. The type of ground truth used:
The "ground truth" for this device's performance is established by objective measurements and validated test methods specified in international standards such as:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993 series (Biological evaluation of medical devices)
This is a form of objective laboratory data compliant with recognized standards.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is relevant for this device.
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Image /page/0/Picture/2 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized representation of human profiles facing to the right. The emblem is positioned in the center of the circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 2235 E Francis St Ontario. California 91761
Re: K171898
Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460
Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC. Dated: June 22, 2017 Received: June 26, 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.
{1}------------------------------------------------
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 (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,
Tara A. Ryan -S
for Lori Wiggins
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) K171898
Device Name
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
| Indications for Use (Describe) | ||||
|---|---|---|---|---|
| This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In | ||||
| addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. | ||||
| The following chemicals have been tested with these gloves. | ||||
| The tested chemotherapy drugs' breakthrough detection times are listed as follows: | ||||
| Chemotherapy DrugMinimum BDT | ||||
| Carmustine, 3.3 mg/ml 16.0 min. | ||||
| Cisplatin, 1.0 mg/ml>240 min. | ||||
| Cyclophosphamide (Cytoxan) , 20 mg/ml>240 min. | ||||
| Doxorubicin Hydrochloride, 2.0 mg/ml >240 min. | ||||
| Etoposide (Toposar) , 20.0 mg/ml>240 min. | ||||
| Fluorouracil, 50.0 mg/ml>240 min. | ||||
| Methotrexate, 25 mg/ml>240 min. | ||||
| Paclitaxel (Taxol) , 6.0 mg/ml >240 min. | ||||
| Thiotepa, 10.0 mg/ml 16.6 min. | ||||
| Vincristine Sulfate, 1.0 mg/ml >>240 min | ||||
| Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) | ||||
| has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
minutes. WARNING: Do not use with Carmustine and Thio-Tepa.
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) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR $07.92.
The assigned 510(K) numbers: K171898
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: August 11, 2017
2. Name of the Device:
Trade Name: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves Classification Regulation: 21 CFR878.4460 Product Code: KGO LZC Classification Panel: General and Plastic Surgery Device Class: Class I
3. Predicate Device Information:
Medline Industries, Inc. 1 Medline Place, Mundelein, IL 60060 SensiCare PI Surgical Glove (K152428)
4. Device Description:
The subject device is single-use disposable powder-free surgical glove that is supplied
{5}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
5. Intended for Use:
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
The following chemicals have been tested with these gloves.
The tested chemotherapy drugs' breakthrough detection times are listed as follows:
| Chemotherapy Drug | Minimum BDT |
|---|---|
| Carmustine, 3.3 mg/ml | 16.0 min. |
| Cisplatin, 1.0 mg/ml | >240 min. |
| Cyclophosphamide (Cytoxan) , 20 mg/ml | >240 min. |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 min. |
| Etoposide (Toposar) , 20.0 mg/ml | >240 min. |
| Fluorouracil, 50.0 mg/ml | >240 min. |
| Methotrexate, 25 mg/ml | >240 min. |
| Paclitaxel (Taxol) , 6.0 mg/ml | >240 min. |
| Thiotepa, 10.0 mg/ml | 16.6 min. |
| Vincristine Sulfate, 1.0 mg/ml | >240 min |
Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes
6. Technological Characteristics:
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is substantially equivalent to the predicate, K152428, SensiCare PI Surgical gloves. Both gloves have the same intended use, same material and the same device performance.
| Device Characteristic | Predicate Device | Subject Device | Comparison Analysis |
|---|---|---|---|
| Device Class | Class I | Class I | similar |
| 510K | K152428 | K171898 | / |
| Product Code | KGO LZC | KGO LZC | similar |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | similar |
| Regulation Name | Surgeon's | Surgeon's | similar |
| Indications for Use | The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In | This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. | similar |
| addition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTM D6978Standard Practice for Assessmentof Medical Gloves to Permeationby Chemotherapy Drugs.Warning: Do not use withCarmustine and Thiotepa | Please note that the followingdrugs have extremely lowpermeation time of less than 30minutes. Carmustine (3.3 mg/ml)has a minimum breakthroughtime of 16.0 minutes; andThiotepa (10.0 mg/ml) has aminimum breakthrough time of16.6 min | ||
| Size | 51/2, 6, 61/2, 7, 71/2, 8, 81/2, 9 | similar | |
| Materials | Polyisoprene | similar | |
| Color | Cream colored | similar | |
| Dimensions-Length | Meets ASTM D3577270mm min. | similar | |
| Dimensions-Width | Meets ASTM D357751/2-70±6mm6-76±6mm61/2-83±6mm7-89±6mm71/2-95±6mm8-102±6mm81/2-108±6mm9-114±6mm | similar | |
| Dimensions-FingerThickness | Meets ASTM D35770.10mm min. | similar | |
| Dimensions-PalmThickness | Meets ASTM D35770.10mm min. | similar | |
| Dimensions-CuffThickness | Meets ASTM D35770.10mm min. | similar | |
| Physical Properties | Meets ASTM D3577Before AgingTensile Strength - 17 MPa minUltimate Elongation – 650% minStress at 500% Elongation – 7.0MPa minMeets ASTM 3577After AgingTensile Strength - 12 MPa minUltimate Elongation – 490% min | similar | |
| Freedom from holes | Meets 21 CFR 800.20 andASTM D3577 when tested inaccordance with ASTM D5151Inspection Level 1, AQL 1.5 | similar | |
| Powder-Free-ResidualPowder | <2mg of residual powderwhen tested in accordancewith ASTM D3577 | similar | |
| Sterility AssuranceLevel (SAL) | 10⁻⁶SAL | 10⁻⁶SAL | similar |
| Biocompatibility | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | similar |
| Chemotherapy DrugsTested | Carmustine 10.1Cisplatin>240Cyclophosphamide>240Doxorubicin Hydrochloride> 240Etoposide>240Fluorouracil>240Methotrexate>240Paclitaxel>240Thiotepa 11.6Vincristine Sulfate>240Cytarabine>240Dacarbazine >240Ifosfamide >240Mitomycin >240Mitoxantrone >240 | Carmustine, 16.0 Cisplatin,>240Cyclophosphamide>240Doxorubicin Hydrochloride>240Etoposide >240Fluorouracil, >240Methotrexate, >240Paclitaxel >240Thiotepa, 16.6Vincristine Sulfate>240 | similar |
| Elements contained on product Labeling | |||
| Product Identifier | Yes | Yes | similar |
| Size | Yes | Yes | similar |
| Single use only | Yes | Yes | similar |
| Country ofmanufacturing | Yes | Yes | similar |
| List of chemotherapydrugs andbreakthrough times | Yes | Yes | similar |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
8.Performance Data
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), ASTM D6124-06(2011) and ASTM D6978. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
9. Summary of clinical Testing
This section does not apply. No clinical testing was performed.
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
10. Conclusion:
The nonclinical testing performed on the Sterile Polyisoprene Powder Free Surgical Gloves, Tested for use with Chemotherapy Drugs demonstrates that this device is as safe, as effective, and performs as well as the predicate device SensiCare PI Surgical Glove, previously cleared under K152428, 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).