(30 days)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.
Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.
However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.
Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.
| Referenced Standards / Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319-19) | Passed | |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass (All size ≥290mm reported in 510(k) Summary, page 5) |
| Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass (Reported ranges: XS: 76-78mm; S: 86-88 mm; M: 96-98mm; L: 106-108 mm; XL: 116-118 mm; XXL: 126-128 mm) |
| Thickness (Finger & Palm) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass (Reported ranges: Palm: 0.09-0.11mm; Finger: 0.13-0.14mm) |
| Physical Properties (ASTM D6319-19, ASTM D412-16 (2021)) | Passed | |
| Tensile Strength (Before Aging) | Min 14 MPa | Pass (Reported range: 15.8-20.8 MPa) |
| Tensile Strength (After Accelerated Aging) | Min 14 MPa | Pass (Reported range: 15.6-19.8 MPa) |
| Ultimate Elongation (Before Aging) | Min 500% | Pass (Reported range: 500-560%) |
| Ultimate Elongation (After Accelerated Aging) | Min 400% | Pass (Reported range: 400-500%) |
| Freedom from holes (ASTM D6319-19, ASTM D5151-19) | G-I, AQL 2.5 | Pass (Meet AQL2.5 requirements) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2 mg/glove | Pass (≤ 2 mg, meet requirements) |
| Chemical Permeation (ASTM D6978-05 (2019)) | Passed (Refer to specific drug breakdown for values) | |
| Chemotherapy Drugs | See "Indications for Use" table on pages 3 and 6, and "Chemotherapy Permeation Comparison Claim" table on pages 7-8 for specific minimum BDTs for 15 listed drugs. | All reported BDTs met or exceeded the minimum requirements. For example, Carmustine (BCNU) had a BDT of 54.3 min (meeting criteria), and many others had >240 min. |
| Opioid Drug (Fentanyl Citrate Injection) | Minimum BDT >240 minutes | >240 minutes |
| Biocompatibility (ISO 10993-10:2010) | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| Biocompatibility (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.
The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.
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 a physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:
- Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
- Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
- Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
- Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
- Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2023
Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China
Re: K232039
Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ
Dear Wu Yuli:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on August 9, 2023. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-2261, or Bifeng. Qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
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
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Image /page/1/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services logo. The second logo is the FDA U.S. Food & Drug Administration logo.
Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China
Re: K232039
Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: July 5, 2023 Received: July 10, 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Allan-Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232039
Device Name
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 196.7 |
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
Minimum BDT (Minutes) Opioid Drug Fentanyl Citrate Injection (100mcg/2mL) >240 Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
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: K232039
Date Prepared: August 09, 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
Contact: Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
2. Name of the Device:
Trade Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC, QDO, OPJ Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250) Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC Device Class: Class I
4. Device Description:
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
Specification for subject device: Acceptance Criteria Results Items Length Minimum 230mm All size ≥290 XS: 70±10mm 76-78mm Palm Width S: 80±10mm 86-88 mm
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| M:95±10mm | 96 -98mm | |
|---|---|---|
| L:110±10mm | 106-108 mm | |
| XL: 120±10mm | 116-118 mm | |
| XXL: 130±10mm | 126-128 mm | |
| Thickness | Palm: 0.05mm (min) | 0.09-0.11mm |
| Finger: 0.05mm (min) | 0.13-0.14mm | |
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Freedom from holes | G-I, AQL 2.5 | Meet AQL2.5requirements |
| Powder-Content | <2 mg per glove | ≤ 2 mg, meet requirements |
Gloves meet all the specification listed in ASTM D 6319-19.
5. Device Modification
The proposed modification to the predicate device is add the claim which tested for use with fentanyl citrate besides claim use with Chemotherapy drugs. We have tested the proposed device (exactly same as predicate device) for use with fentanyl citrate as per ASTM D6978 and gotten the testing report to support this claim. Please note that there are no any differences with these two gloves from materials, manufacturing process and bench performance.
6. Indications for Use:
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 196.7 |
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| Opioid Drug | Minimum BDT (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
7. Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
| Items | Predicate DeviceK220250 | Subject DeviceK232039 | Result ofcomparison |
|---|---|---|---|
| Trade Name | Sterile Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs | Sterile Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs andFentanyl Citrate | Different* |
| Product Code | LZA, LZC | LZA, LZC, OPJ, QDO | Different* |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Description | Sterile Examination glove | Sterile Examination glove | Same |
| Indications for Use | Sterile Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. In additionthese gloves were tested for usewith Chemotherapy drugs inaccordance with ASTM D6978. | The glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. Inaddition these gloves weretested for use withChemotherapy drugs andfentanyl citrate in accordancewith ASTM D6978. | Different* |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Sterility | Sterile | Sterile | Same |
| Single use | Single use | Single use | Same |
| ChemotherapyDrug PermeationClaim | See below comparison table | See below comparison table | / |
*This different is support with test report and will be indicated on labeling.
Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | Result ofcomparison | |
|---|---|---|---|
| Predicate DeviceK220250 | Subject DeviceK232039 |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| Carmustine (BCNU) (3.3mg/ml) | 54.3 | 54.3 | Same |
|---|---|---|---|
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 196.7 | 196.7 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 | Same |
| Cytarabine HCL (100mg/ml) | >240 | >240 | Same |
| Mitoxantrone (2.0 mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Ifosfamide (50.0 mg/ml) | >240 | >240 | Same |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 | Same |
| Opioid Drug and Concentration | Minimum BDT (Minutes) | Result ofcomparison | |
|---|---|---|---|
| Predicate DeviceK220250 | Subject DeviceK232039 | ||
| Fentanyl Citrate Injection (100mcg/2mL) | / | >240 | Different* |
*This different is support with test report and will be indicated on labeling.
Dimensions and Performance Comparison Table:
| Technological | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Characteristics | K232039 | K220250 | |
| Length | Minimum 230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | |||
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before | 14MPa, min | 14MPa, min | Same |
| Aging | |||
| Ultimate Elongation, | 500%, min | 500%, min | Same |
| Before Aging | |||
| Tensile Strength, After | 14MPa, min | 14MPa, min | Same |
| Accelerated Aging | |||
| Ultimate Elongation, | 400%, min | 400%, min | Same |
| After Accelerated Aging | |||
| Freedom from holes | In accordance with ASTM D | In accordance with ASTM D | Same |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| 5151-19, following ASTMD6319-19, G-I, AQL 2.5 | 5151-19, following ASTMD6319-19, G-I, AQL 2.5 | ||
|---|---|---|---|
| Residual Powder | ≤2 mg per glove | ≤2 mg per glove | Same |
8. Summary of Non-Clinical Testing
Non-clinical tests were performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Referenced standards | Test Performed/Prupose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XSand S, 230mm for size M, L, XL | Pass |
| ASTM D6319- 19 | Physical Dimensions PalmWidth | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mmXXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min14 Mpa)and Elongation (Before Aging500% and after aging 400%) Min | Pass |
| ASTM D6319- 19ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, OpioidDrug Permeation | Refer the above tables | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skinirritation | Is non-sensitization andNon-irritation |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence ofacute systemictoxicity. |
8. Summary of Clinical Information:
No clinical testing was submitted for the subject device.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.