(100 days)
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).
The provided document is a 510(k) Premarket Notification from the FDA regarding Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.
This document does not describe the acceptance criteria and study proving a software algorithm device meets these criteria, but rather the acceptance criteria and test results for a physical medical device (examination gloves).
Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device and the information provided in the 510(k) summary.
However, I can extract the relevant information about the acceptance criteria and the device's performance based on the provided document.
Device: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Type of Device: Physical Medical Device (Examination Gloves), Class I, reserved
Study Purpose: To demonstrate substantial equivalence to a predicate device (Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)) by verifying that the subject device meets specific performance standards and has similar technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables detailing the acceptance criteria (standards/specifications) and the results indicating that the device meets these criteria.
| Item/Test | Acceptance Criteria (Standard/Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensions | ||
| Length | Minimum 230mm | All size ≥290mm |
| Palm Width (XS) | 70 ± 10mm | 76-78mm |
| Palm Width (S) | 80 ± 10mm | 86-88mm |
| Palm Width (M) | 95 ± 10mm | 96-98mm |
| Palm Width (L) | 110 ± 10mm | 106-108mm |
| Palm Width (XL) | 120 ± 10mm | 116-118mm |
| Palm Width (XXL) | 130 ± 10mm | 126-128mm |
| Physical Properties (Thickness) | ||
| Thickness (Palm) | 0.05mm (min) | 0.09-0.11mm |
| Thickness (Finger) | 0.05mm (min) | 0.13-0.14mm |
| Physical Properties (Tensile Strength) | ||
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Physical Properties (Ultimate Elongation) | ||
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Integrity | ||
| Freedom from holes | G-I, AQL 2.5 (per ASTM D5151-19, ASTM D6319-19) | Meet and above AQL 2.5 requirements |
| Powder Content | ≤ 2 mg per glove (per ASTM D6124-06(2017), ASTM D6319-19) | ≤ 2 mg, meet requirements |
| Biocompatibility | ||
| Primary Skin Irritation Test | Not an irritant (per ISO 10993-10:2010) | Not an irritant |
| Dermal Sensitization Assay | Not a sensitizer (per ISO 10993-10:2010) | Not a sensitizer |
| Acute Systemic Toxicity Test | No evidence of systemic toxicity (per ISO 10993-11:2017) | No evidence of systemic toxicity |
| Chemotherapy Drug Permeation (Minimum Breakthrough Time - BDT) | ||
| Carmustine (BCNU) (3.3mg/ml) | - (Predicate: 39 min) | 54.3 minutes |
| Cyclophosphamide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Doxorubicin Hydrochloride (2 mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Etoposide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Fluorouracil (50mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Paclitaxel (6mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Thiotepa (10mg/ml) | - (Predicate: 97.6 min) | 196.7 minutes |
| Methotrexate (25mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Cisplatin (1mg/ml) | - (Predicate: N/A) | >240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Cytarabine HCL (100mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
(Note: For chemotherapy drug permeation, the "Acceptance Criteria" are implied by comparison to the predicate device and showing equivalent or better performance. The exact criteria are not explicitly stated for each drug beyond the measured BDT.)
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "samples" in the way a software algorithm test set would be. The testing is based on batches of gloves or representative samples according to the referenced ASTM/ISO standards. For example, "Freedom from holes" testing follows an AQL (Acceptance Quality Limit) which implies a sampling plan.
- Data Provenance: The tests are non-clinical and conducted based on international standards (ASTM, ISO). The manufacturer is Grand Work Plastic Products Co., Ltd, located in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing would have been performed there or at certified labs used by the manufacturer. The data is retrospective in the sense that it was collected as part of the device's development and qualification prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this physical device's performance (e.g., tensile strength, breakthrough time) is established by adherence to standardized physical and chemical testing methods (ASTM, ISO standards), not by human expert consensus or clinical judgment in the traditional sense of diagnostic AI. These standards define the test procedures and acceptance limits.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human reader adjudication. Performance is measured by laboratory equipment and standard 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 not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is established through standardized physical, chemical, and biological testing methods as defined by:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06(2017) (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)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 11, 2022
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K220250
Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 12, 2022 Received: February 17, 2022
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. 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.
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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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD 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) K220250
Device Name
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
| 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 |
| 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)
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR $807.92.
The assigned 510(K) number is: K220250
Date Prepared: January 20, 2022
- Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA and LZC Device Class: Class I
3. Predicate Device Information:
Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)
4. Device Description:
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).
5. Indications for Use:
A patient examination 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 provides protection against following chemotherapy drugs and the minimum breakthrough time are listed as follows.
| 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 |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
| 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 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
6. Specification for Nitrile Gloves:
| Items | Acceptance Criteria | Results |
|---|---|---|
| Length | Minimum 230mm | All size ≥290 |
| Palm Width | XS: 70±10mm | 76-78mm |
| S: 80±10mm | 86-88 mm | |
| 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 and above AQL2.5requirements |
| Powder-Content | ≤2 mg per glove | ≤ 2 mg, meet requirements |
Gloves meet all the specification listed in ASTM D 6319-19.
7. Technological Characteristic Comparison:
| Characteristics | Subject Device | Predicate Device K190725 | Comparison |
|---|---|---|---|
| Trade Name | Sterile Powder Free NitrileExamination Gloves (Blue), Testedfor Use with Chemotherapy Drugs | Nitrile Examination GlovesSterile Tested for Use withChemotherapy Drugs claim, White | Similar |
| Product Code | LZA and LZC | LZA and LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
| Class | I | I | Same |
|---|---|---|---|
| Indications for Use | Subject device is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | Predicate device is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | Same |
| Description | Sterile Examination glove made ofNitrile and color Blue and testedwith chemotherapy Drugs | Sterile Examination glove made ofNitrile and color White and tested withchemotherapy Drugs | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | White | Different |
| Sterility ISO 11737-2EN ISO 11137-2 | Sterility | Sterility | Same |
| Single used | Single used | Single used | Same |
| Non Sterile or Sterile | Sterile | Sterile | Same |
| 10993-10:2010 SkinIrritation Study | Under the conditions of thestudy, not an irritant | Under the conditions of the study,not an irritant | Same |
| 10993-10:2010Maximization SensitizationStudy | Under the conditions of thestudy, not a sensitizer | Under the conditions of the study,not a sensitizer | Same |
| ISO 10993 Part 11Acute Systemic ToxicityTest | Under the conditions of this study,there was no evidence of systemictoxicity. | Under the condition of this study,Nitrile Examination glove, sterileshows no adverse biological reaction | Same |
Dimensions and Performance Comparison Table:
| TechnologicalCharacteristics | Subject Device | Predicate DeviceK190725 | Comparison |
|---|---|---|---|
| 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 | / | Different |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,Before Aging | 500%, min | 500%, min | Same |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
| Tensile Strength, AfterAccelerated Aging | 14MPa, min | 14MPa, min | Same |
|---|---|---|---|
| Ultimate Elongation, AfterAccelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with ASTM D5151-19, following ASTMD6319- 19, G-I, AQL 2.5 | In accordance with ASTM D5151-19, following ASTMD6319- 19, G-I, AQL 2.5 | Same |
| Residual Powder | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
Chemotherapy Permeation Comparison:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Subject Device | Predicate DeviceK190725 | ||
| Carmustine (BCNU) (3.3mg/ml) | 54.3 | 39 | Similar |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Cytarabine (1.0 mg/ml) | / | >240 | Different |
| 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 | 97.6 | Similar |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | / | Exceed |
| Vincristine Sulfate (1.0 mg/ml) | >240 | / | Exceed |
| Cytarabine HCL (100mg/ml) | >240 | / | Exceed |
| Mitoxantrone (2.0 mg/ml) | >240 | / | Exceed |
| Mitomycin C (0.5 mg/ml) | >240 | / | Exceed |
| Ifosfamide (50.0 mg/ml) | >240 | / | Exceed |
| Dacarbazine (10.0 mg/ml) | >240 | / | Exceed |
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:
| Test Methodology | Purpose | AcceptanceCriteria | Result Summary |
|---|---|---|---|
| ASTM D6319-19 | The purpose of the testing is tomeasure the dimensions of thesubject device. | XS-70±10S-80±10M-95±10L-110±10XL-120±10XXL-130±10 | Meets |
| ASTM D6319-19 | The purpose of the testing is tomeasure the physical properties of | Finger - Minimum 0.05 | Meets |
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ggao Industrial Zone, Zanhuang, Hebei, 050000, China
| the subject device. | Palm - Minimum 0.05 | ||
|---|---|---|---|
| Tensile Strength, before aging -14MPa, min | |||
| Ultimate Elongation, Before Aging -500%, min | |||
| Tensile Strength, After AcceleratedAging - 14MPa, min | |||
| UltimateElongation, AfterAcceleratedAging - 400%,mi | |||
| ASTM D6319- 19ASTM D5151-19 | The purpose of the testing is tomeasure the freedom from holes ofthe subject device. | In accordance with ASTM D5151-19, following ASTMD6319- 19, G-I,AQL 2.5 | Meets |
| ASTM D 6124-06(2017)ASTM D6319- 19 | The purpose of the testing is tomeasure the residual powder on thesubject device. | ≤2 mg per glove | Meets |
| ISO 10993-10:2010 | The purpose of the testing is tomeasure the primary skin irritationtest of the subject device. | Under the conditions of the study thedevice extracts were not an irritant | Meets |
| ISO 10993-10:2010 | The purpose of the testing is tomeasure the Dermal sensitizationassay of the subject device. | Under the conditions of the studythe device extracts were not asensitizer | Meets |
| ISO 10993-11:2017 | The purpose of the testing is tomeasure the Acute SystemicToxicity of the subject device. | Under the conditions of this study,there was no evidence of systemictoxicity for the device extracts. | Meets |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
The subject device meets the applicable requirements for patient examination gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 and ISO 10993-11.
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 predicated 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.