(128 days)
The 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.
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided text describes the acceptance criteria and the study that proves a medical device (Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs) meets those criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily assessed against ASTM standards and biocompatibility tests. The table below summarizes these, focusing on the key performance characteristics relevant to general surgical gloves and their resistance to chemotherapy drugs.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties (per ASTM D3577-19) | ||
| Length (size 5.5) | ≥ 245 mm | 283-308 mm |
| Length (size 6-9) | ≥ 265 mm | 283-308 mm |
| Palm Width (e.g., size 5.5, 6.0, etc.) | Specific ranges (e.g., 5.5: 70±6 mm, 6.0: 76±6 mm, etc.) | Average values within specified ranges (e.g., 5.5: 72 mm, 6.0: 76 mm) |
| Finger Thickness | Minimum 0.10 mm | 0.20-0.26 mm |
| Palm Thickness | Minimum 0.10 mm | 0.19-0.24 mm |
| Cuff Thickness | Minimum 0.10 mm | 0.16-0.19 mm |
| Tensile Strength, Before Aging | ≥ 24 MPa | Average 24-29 MPa |
| Ultimate Elongation, Before Aging | ≥ 750 % | Average 750-851% |
| Stress at 500% Elongation | ≤ 5.5 MPa | Average 2.1-4.5 MPa |
| Tensile Strength, After Accelerated Aging | ≥ 18 MPa | Average 18-25 MPa |
| Ultimate Elongation, After Accelerated Aging | ≥ 560 % | Average 610-796 % |
| Other Performance Metrics | ||
| Freedom from holes (per ASTM D3577-19, ASTM D 5151-19) | AQL 1.5 requirements | Meets AQL 1.5 |
| Powder-Free (per ASTM D3577-19, ASTM D6124-06 (2022)) | ≤ 2 mg per glove | 0.09-0.12 mg per glove |
| Aqueous Extractable Protein Content (per ASTM D3577-19, ASTM D5712-15) | ≤ 200 ug/dm² | 0.07-0.34 ug/dm² |
| Sterility Assurance Level | 10-6 SAL | 10-6 SAL |
| Chemotherapy Drug Permeation (per ASTM D6978-05 (2019)) | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | Minimum Breakthrough Detection Time (BDT) based on predicate/reference devices (typically >240 minutes for most drugs, except Carmustine and Thiotepa) | >240 minutes |
| Busulfan 6mg/ml (6,000 ppm) | - | >240 minutes |
| Carboplatin 10mg/ml (10,000 ppm) | - | >240 minutes |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | Comparative to predicate/reference (e.g., predicate 13.2 min, reference 12.6 min) | 14.0 minutes (Note: Warning: Do not use with Carmustine) |
| Cisplatin 1mg/ml (1,000 ppm) | - | >240 minutes |
| Cyclophosphamide 20mg/ml (20,000 ppm) | - | >240 minutes |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | - | >240 minutes |
| Dacarbazine 10 mg/ml (10,000 ppm) | - | >240 minutes |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Etoposide, 20 mg/ml (20,000 ppm) | - | >240 minutes |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Fludarabine, 25 mg/ml (25,000 ppm) | - | >240 minutes |
| Fluorouracil, 50mg/ml (50,000ppm) | - | >240 minutes |
| Idarubicin HCL, 1mg/ml (1,000ppm) | - | >240 minutes |
| Ifosfamide, 50mg/ml (50,000ppm) | - | >240 minutes |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | - | >240 minutes |
| Melphalan, 5mg/ml (5,000ppm) | - | >240 minutes |
| Methotrexate, 25mg/ml (25,000ppm) | - | >240 minutes |
| Mitomycin C, 0.5mg/ml (500ppm) | - | >240 minutes |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | - | >240 minutes |
| Paclitaxel, 6mg/ml (6,000ppm) | - | >240 minutes |
| Paraplatin, 10mg/ml (10,000ppm) | - | >240 minutes |
| Rituximab, 10mg/ml (10,000ppm) | - | >240 minutes |
| Thio Tepa, 10mg/ml (10,000ppm) | Comparative to predicate/reference (e.g., predicate 12.0 min, reference 22.4 min) | 16.1 minutes (Note: Warning: Do not use with Thiotepa) |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | - | >240 minutes |
| Biocompatibility (per ISO 10993 series) | ||
| Skin Sensitization (ISO 10993-10) | No significant evidence of causing skin sensitization | No significant evidence of causing skin sensitization |
| Intracutaneous Reactivity (ISO 10993-23) | Polar and non-polar extract score less 1.0 | Test met requirements (score less 1.0) |
| Cytotoxicity (ISO 10993-5) | Acceptable level of cytotoxicity (comparison to predicate for "grade 2 at 1:16 dilution, grade 0 at 1:32 and 1:64 dilutions") | Showed potential toxicity to L929 cells (Note: This is presented as meeting the acceptance criteria by the submitter, implying it's acceptable for the device type) |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity |
| Material-mediated Pyrogenicity (ISO 10993-11) | No rabbit shows an individual rise in temperature of 0.5°C or more | Test met requirements (no rabbit showed individual rise in temperature of 0.5°C or more) |
| Endotoxin | <20 EU/glove | <20 EU/glove |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications." The testing was conducted in accordance with recognized international and national standards (ASTM, ISO, U.S. Pharmacopeia).
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the listed ASTM and ISO standards for each test (e.g., AQL 1.5 for freedom from holes implies a certain sample size for inspection).
- Data Provenance: The manufacturer is "Grand Work Plastic Products Co., Ltd." in "Zanhuang, Hebei, 050000 China." The tests would have been performed by or for this company. The document does not specify if the testing was performed in China or by an external laboratory.
- Retrospective or Prospective: The testing described is prospective, as it involves evaluating a new device against predefined standards to support its market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information (number and qualifications of experts) is generally relevant for studies involving subjective interpretation, especially in AI/imaging devices. For the physical and chemical testing of surgical gloves, "ground truth" is established by adherence to standardized test methods (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). The "experts" in this context would be the technicians and scientists performing and interpreting these standardized tests in a laboratory setting, who are qualified to execute these specific methodologies. Their specific number or individual qualifications are not detailed in this type of regulatory submission but are assumed to meet the requirements of the testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or expert review processes where there is subjective interpretation involved, especially for ground truth establishment in medical imaging or diagnostic devices. For the non-clinical physical, chemical, and biocompatibility testing of surgical gloves, such adjudication methods are not applicable. The results are obtained through objective measurements and standardized protocols with predetermined pass/fail criteria.
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
No. An MRMC comparative effectiveness study is not relevant for this device. This is a physical medical device (surgical glove), not an AI-powered diagnostic or assistive technology that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept is not applicable to a physical surgical glove. "Standalone" performance testing for this device refers to its physical and chemical properties and its barrier properties, measured objectively according to specified standards, without any "human-in-the-loop" component in its performance itself (though human labor is involved in its use).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established industry standards and objective physical/chemical measurements. Specifically:
- ASTM D3577-19: Standard Specification for Rubber Surgical Gloves (defines dimensions, physical properties, freedom from holes).
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (2022): Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (defines the permeation testing methodology).
- ASTM D5712-15 (2020): Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ISO 10993 series: Biological evaluation of medical devices (for biocompatibility tests like cytotoxicity, sensitization, systemic toxicity, pyrogenicity).
- U.S. Pharmacopeia: Sterility Test.
The pass/fail criteria and metric values within these standards serve as the "ground truth."
8. The sample size for the training set
This is not applicable. The device is a physical product (surgical glove), not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
December 20, 2023
Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang County, Hebei 050000 China
Re: K232444
Trade/Device Name: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: November 20, 2023 Received: November 20, 2023
Dear Wu Yuli:
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"
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(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 medical devices and radiation-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.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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
510(k) Number (if known) K232444
Device Name
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The 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.
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes Warning: Do not use with Carmustine and Thiotepa
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K232444 Date Prepared: December 16, 2023
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668 Email: fdareg(@hongray.com.cn Contact: Mrs. Wu Yuli Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Email: janicema@hongrayusa.com
2. Name of the Device:
Trade Name: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs Common Name: Surgeon's Glove Classification Name: Surgeon's Glove Classification Regulation: 21 CFR 878.4460 Product Code: KGO, LZC, OPJ Device Class: Class 1
3. Predicate Device Information:
Primary Predicate Device: Careplus (M) SDN BHD ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765).
Reference device:
Medline Industries, Inc.
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50ug/dm2 per Glove of Extractable Protein (K202668) This reference device is being used to support inclusion of additional chemotherapy drugs that were not tested in the predicate.
4. Device Description:
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
5. Indications for Use:
The glove is intended to be worn by operating room personnel to protect surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
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| Carboplatin 10mg/ml (10,000 ppm) | >240 |
|---|---|
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes Warning: Do not use with Carmustine and Thiotepa
6. Comparison table of Subject Device and Predicate Device:
| Items | Subject DeviceK232444 | Predicate DeviceK202765 | Remark | |
|---|---|---|---|---|
| Trade Name | Sterile Powder Free Latex SurgicalGloves, Tested for Use withChemotherapy Drugs | ENCORE Latex Textured SurgicalGloves, Powder Free with ProteinContent Labeling Claim (50micrograms or less) and Tested foruse with Chemotherapy drugs | Similar* | |
| Product Code | KGO, LZC, OPJ | KGO, LZC | Same | |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Classification | I | I | Same | |
| Regulation Name | Surgeon's Glove | Surgeon's Glove | Same | |
| Indications for Use | Sterile Powder Free Latex SurgicalGloves, Tested for Use withChemotherapy Drugs is intended to beworn by operating room personnel toprotect a surgical wound fromcontamination. In addition, thesegloves were tested for use withchemotherapy drugs in accordancewith ASTM D6978. | Powder Free Surgical Gloves aresterile disposable devices intended tobe worn by operating room personnelto protect surgical wound fromcontamination.These gloves were tested for use withchemotherapy drugs as per ASTMD6978 Standard Practice forAssessment of Resistance of MedicalGloves to Permeation byChemotherapy. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Materials | Latex | Latex | Same | |
| Color | Natural | Natural | Same | |
| SingleUse/Disposable | Single Use | Single Use | Same | |
| Sterility | Sterile | Sterile | Same | |
| Sterilizationmethod | Radiation sterilization | Radiation sterilization | Same | |
| Sterility AssuranceLevel (SAL) | 10-6 | 10-6 | Same | |
| Shelf-life/expirationdate | 3 years | Not available | Different** | |
| Freedom fromholes | Meets ASTM D3577-19 requirementsof AQL 1.5 | Meets ASTM D3577-19 requirementsof AQL 1.5 | Same | |
| Length | 5.5: ≥ 245 mm6-9: ≥ 265 mm | 5.5: ≥ 245 mm6-9: ≥ 265 mm | Same | |
| Dimensions | 5.5:70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | 5.5:70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | Same | |
| Thickness | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mmFinger Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mmFinger Thickness: ≥ 0.10 mm | Same | |
| PhysicalProperties | Tensile Strength Before Aging: ≥ 24MPaTensile Strength After Aging: ≥ 18MPaUltimate Elongation Before Aging: ≥750 %Ultimate Elongation After Aging: ≥560 % | Tensile Strength Before Aging: ≥ 24MPaTensile Strength After Aging: ≥ 18MPaUltimate Elongation Before Aging: ≥750 %Ultimate Elongation After Aging: ≥560 % | Same | |
| Powder residual | Residual Powder: ≤ 2 mg per glove | Residual Powder: ≤ 2 mg per glove | Same | |
| In VitroCytotoxicity | Under the conditions of this study, thetest article extract showed potentialtoxicity to L929 cells. | Under the conditions of this study,the test material is cytotoxic (grade 4)at undiluted, 1:2, 1:4, 1:8 dilutions;and Non-cytotoxic, grade 2 at 1:16dilution, grade 0 at 1:32 and 1:64dilutions | Same | |
| Acute SystemicToxicity | Under the conditions of this study,there was no evidence of acutesystemic toxicity from the extract.The test article extract met therequirements of this study. | Under the conditions of this study,the test material both inner and outersurface did not reveal systemictoxicity | Same | |
| Primary SkinIrritation | The test result showed that the polarand non-polar extract of the final testsample score is less 1.0, therequirements of the test are met. | Under the conditions of this study,the test material did not cause andirritant response. | Same | |
| DermalSensitization | Under the conditions of this study, thetest article extract showed nosignificant evidence of causing skin | Under the conditions of this study,the test material did not produce askin sensitization effect. | Same | |
| sensitization | ||||
| Material-MediatedPyrogenicity Test | The test article meets the requirementsof pyrogen test. | Non-Pyrogenic | Same | |
| Endotoxin | <20 EU/glove | Not available | Different*** | |
| ChemotherapyDrugPermeation Claim | See below comparison table | See below comparison table | / | |
| Protein Label Claim | No protein claim | Contains 50 micrograms or less oftotal water extractable protein pergram. | Different**** |
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*The trade name will be indicated on labeling and it does not raise concerns of safety and does not affect the substantial equivalence in effectiveness and safety.
**The shelf life will be indicated on labeling, so this different does not raise safety and effectiveness concerns. ***The endotoxin is the required test item on surgical gloves and it will be supported with test report, so the difference does not raise concerns of safety and effectiveness.
****The protein claim will not be indicated on labeling of subject device, so the difference does not raise concerns of safety and effectiveness and does not affect the substantial equivalence in effectiveness and safety.
Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum Breakthrough Detection Time (Minutes) | Remark(Compare withK202668) | ||
|---|---|---|---|---|
| Subject DeviceK232444 | Predicate DeviceK202765 | Reference DeviceK202668 | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | / | >240 | Same |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 | 13.2 | 12.6 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | / | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | / | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | / | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | / | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | / | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | / | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | / | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | / | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 | 12.0 | 22.4 | Similar |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
Note: The permeation times of Carmustine and Thio Tepa will be listed on labeling and will add the warning "Do not use with Carmustine and Thiotepa", so this similar does not raise concerns of safety and effectiveness.
{9}------------------------------------------------
7 Summary of Non-Clinical Testing
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.
- ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- · ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves
- · ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs
• ASTM D5712-15 (2020) Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-23 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- · ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogen Test
- · U.S. Pharmacopeia Sterility Test
8. Specification for subject Gloves:
| TechnologicalCharacteristics | Standard/Test/FDAGuidance | Result Summary | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577requirements for length, widthand thickness | / |
| --Length | 5.5: ≥ 245 mm6-9: ≥ 265 mm | 283-308mm | Pass |
| --Palm Width (size) | (mm) | Average value in mm | / |
| 5.5 | 70±6 | 72 | Pass |
| 6.0 | 76±6 | 76 | Pass |
| 6.5 | 83±6 | 83 | Pass |
| 7.0 | 89±6 | 88 | Pass |
| 7.5 | 95±6 | 95 | Pass |
| 8.0 | 102±6 | 101 | Pass |
| 8.5 | 108±6 | 105 | Pass |
| 9.0 | 114±6 | 110 | Pass |
| --Thickness | Average value in mm | ||
| Finger | Minimum 0.10 | 0.20-0.26 | Pass |
| Palm | Minimum 0.10 | 0.19-0.24 | Pass |
| Cuff | Minimum 0.10 | 0.16-0.19 | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | |
| Tensile Strength,Before Aging | 24MPa, min | Average 24-29 MPa | Pass |
| Ultimate Elongation,Before Aging | 750%, min | Average 750-851% | Pass |
| Stress at 500%Elongation | 5.5 MPa, max | Average 2.1-4.5MPa | Pass |
| Tensile Strength, AfterAccelerated Aging | 18MPa, min | Average 18-25MPa | Pass |
| Ultimate Elongation,After AcceleratedAging | 560%, min | Average 610-796 % | Pass |
{10}------------------------------------------------
| Freedom from holes | ASTM D3577-19ASTM D 5151-19requirements of AQL1.5 | Meets AQL1.5 | Pass |
|---|---|---|---|
| Powder-Free | ASTM D3577-19ASTM D 6124-06(2022)≤ 2 mg per glove | 0.09-0.12mg per glove | Pass |
| Aqueous ExtractableProtein Content | ASTM D3577-19ASTM D5712-15≤200ug/dm² | 0.07-0.34ug/dm² | Pass |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |
9 Biocompatibility
| Test | Result Summary |
|---|---|
| Skin Sensitization TestISO 10993-10 | Under the conditions of this study, the test article extract showed no significantevidence of causing skin sensitization |
| Intracutaneous ReactivityTestISO 10993-23 | The test result showed that the polar and non-polar extract of the final testsample score is less 1.0, the requirements of the test are met. |
| Cytotoxicity TestISO 10993-5 | Under the conditions of this study, the test article extract showed potentialtoxicity to L929 cells. |
| Acute Systemic Toxicity Test10993-11 | Under the conditions of this study, there was no evidence of acute systemictoxicity from the extract.The test article extract met the requirements of this study. |
| Material-mediatedPyrogenicityTest 10993-11 | Under the conditions of this study, no rabbit shows an individual rise intemperature of 0.5°C or more, the test article meets the requirements of pyrogentest. |
| Endotoxin | <20 EU/glove |
10_Clinical Performance Data:
Not applicable.
11. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the Subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).