(123 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. A table of acceptance criteria and the reported device performance
The provided document lists various performance criteria for the Nitrile Powder Free Examination Gloves (Black and Orange) and reports the results against these criteria.
| Characteristic / Test | Acceptance Criteria | Reported Device Performance (Black Gloves) | Reported Device Performance (Orange Gloves) |
|---|---|---|---|
| Freedom From Holes | Meet requirement inspection level G-1, AQL 2.5 Sampling size 125pcs (Ac: 7, Re: 8) | Pass (≤3pcs) | Pass (≤4pcs) |
| Dimension: Length | 220 mm min (small) 230 mm min (other sizes) | 241 mm min | 240 mm min |
| Dimension: Width (S) | 80 ± 10 mm | average 85.5mm | average 85.8mm |
| Dimension: Width (M) | 95 ± 10 mm | average 96.3mm | average 96.1mm |
| Dimension: Width (L) | 110 ± 10 mm | average 106.4mm | average 106.8mm |
| Dimension: Width (XL) | 120 ± 10 mm | average 115.5mm | average 115.9mm |
| Dimension: Width (XXL) | 130 ± 10 mm | average 125.1mm | average 125.6mm |
| Dimension: Thickness (Palm) | Minimum 0.05 mm | 0.178mm min. | 0.181mm min. |
| Dimension: Thickness (Finger) | Minimum 0.05 mm | 0.199mm min. | 0.212mm min. |
| Physical Properties (Before Aging): Tensile Strength | 14 MPa, min. | 15.1 MPa, min. | 15.3 MPa, min. |
| Physical Properties (Before Aging): Elongation | 500%, min. | 518%, min. | 502%, min. |
| Physical Properties (After Aging): Tensile Strength | 14 MPa, min. | 15.0 MPa, min. | 14.1 MPa, min. |
| Physical Properties (After Aging): Elongation | 400%, min. | 460%, min. | 462%, min. |
| Residual Powder Content | Not more than 2 mg per glove | average 0.32mg | average 0.30mg |
| Biocompatibility: Primary Skin Irritation | Not a primary skin irritant | Pass (Conclusion: The test result showed that the response of the test article was categorized as negligible under the test condition) | Pass (Conclusion: The test result showed that the response of the test article was categorized as negligible under the test condition - implied similar from the text for both colors) |
| Biocompatibility: Skin Sensitization | Not a contact sensitizer | Pass (Conclusion: Under the conditions of this study, the test article showed no significant evidence of causing skin sensitization in the guinea pig) | Pass (Conclusion: Under the conditions of this study, the test article showed no significant evidence of causing skin sensitization in the guinea pig - implied similar from the text for both colors) |
| Biocompatibility: Acute Systemic Toxicity | No systemic toxicity | Pass (Conclusion: Under the conditions of this study, there was no evidence of acute systemic toxicity from the extract. The test article extract met the requirements of the study.) | Pass (Conclusion: Under the conditions of this study, there was no evidence of acute systemic toxicity from the extract. The test article extract met the requirements of the study. - implied similar from the text for both colors) |
| Chemotherapy Drugs & Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time in minutes) | As per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. (Specific breakthrough times vary by drug) | ||
| Carmustine (BCNU) | Not explicitly stated as a general minimum, but the document highlights extremely low permeation times for this drug and warns against its use. | 21.6 minutes | 22.7 minutes |
| Cyclophosphamide | >240 min. | >240 min. | >240 min. |
| Doxorubicin HCl | >240 min. | >240 min. | >240 min. |
| Etoposide | >240 min. | >240 min. | >240 min. |
| Fluorouracil | >240 min. | >240 min. | >240 min. |
| Mitomycin C | >240 min. | >240 min. | >240 min. |
| Oxaliplatin | >240 min. | >240 min. | >240 min. |
| Paclitaxel | >240 min. | >240 min. | >240 min. |
| Thiotepa | Not explicitly stated as a general minimum, but the document highlights extremely low permeation times for this drug and warns against its use. | 28 minutes | 37.1 minutes |
| Fentanyl Citrate Injection | >240 min. | >240 min. | >240 min. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Physical/Dimensional/Chemical Tests: For "Freedom From Holes," the sampling size is stated as 125 pieces (Ac: 7, Re: 8). The specific sample size for other physical/dimensional tests (length, width, thickness, tensile strength, elongation, residual powder content) is not explicitly stated, but the tests are reported as meeting ASTM D6319-19 and ASTM D6124-06 requirements. For Biocompatibility tests, no specific sample size is given, but the studies involve guinea pigs and rats, implying animal testing was conducted.
- Sample Size for Chemotherapy Drug Permeation Tests: Not explicitly stated within the document. The tests are reported as per ASTM D6978-05 (Reapproved 2019).
- Data Provenance: The manufacturing company is Dehai (Shandong) Medical Gloves, Co., Ltd. located in Zibo City, Shandong Province, China. The testing would presumably have been conducted in a laboratory, potentially in China or a third-party testing facility. The document doesn't specify if the data is retrospective or prospective, but testing of device performance characteristics is generally prospective for regulatory submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO). There is no "ground truth" established by human experts in the way an AI diagnostic algorithm would require. The "ground truth" is defined by the objective metrics and thresholds specified in the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in studies involving human interpretation (e.g., radiology reads). This document pertains to physical and chemical testing of a medical device against predefined standards, which does not involve such adjudication.
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 document is for a medical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established industry standards and objective material properties. Specifically:
- ASTM D6319-19: Standard specification for Nitrile Examination Gloves.
- ASTM D5151-19: Standard test methods for detection of holes in medical gloves.
- ASTM D6124-06: Standard test method for residual powder on medical gloves.
- ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-23, ISO 10993-10, ISO 10993-11: Biocompatibility standards for medical devices (Primary Skin Irritation, Skin Sensitization, Acute Systemic Toxicity).
These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough time for drugs).
8. The sample size for the training set
Not applicable. This device is a medical glove, not a machine learning model, so 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 this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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 Administration" in blue text.
November 28, 2023
Dehai (Shandong) Medical Gloves, Co., Ltd. % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario, California 91764
Re: K232252
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: October 26, 2023 Received: October 30, 2023
Dear Deze Wang:
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.
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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" (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 Ouality System (OS) 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 QS 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).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232252
Device Name
Nittile Powder Free Examination Gloves Tested for Use with Chemotherapy Drues and Fentaxy, Citrate (Black), Nittle Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange).
Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs and FentanylConcentration | Minimum Breakthrough Detection Time (minutes) | ||
|---|---|---|---|
| Black | Orange | ||
| *Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| *Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| *Please note that following drugs have extremely low permeation times: | |||
| 1. Carmustine (BCNU) | |||
| 2. Thio Tepa | |||
| Warning: Do not use with Carmustine and Thiotepa |
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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510(K) SUMMARY K232252
(As requirement by 21 CFR 807.92)
| Applicant Name | Dehai (Shandong) Medical Gloves, Co., Ltd. |
|---|---|
| Location | No. 216 Huagong Road Linzi District, Zibo City,Shandong Province, China |
| Contact Person: | Li xiaomeng |
| Tel: | +86-13917372099 |
| Date summary prepared: | 16th Nov. 2023Device Information |
| Trade Name: | Nitrile Powder Free Examination Gloves Tested for Use with Ch |
| Trade Name: | Nitrile Powder Free Examination Gloves Tested for Use with ChemotherapyDrugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination GlovesTested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
| Common Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification Name: | Non-Powdered Patient Examination Gloves |
| Product Code: | LZA, LZC, QDO, OPJ |
| Regulation: | 21CFR:880, 6250 |
Predicate Device
NITRILE EXAMINATIONGLOVES POWDERFREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE(BLUE & BLACK), 510(K) number K230121 product code LZA, LZC, QDO, OPJ.
Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large. The Nitrile Examination Gloves Powder Free (Black & Orange) have been tested for Chemotherapy Drugs and Fentanyl Citrate as below:
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DH Medical
| Chemotherapy Drugs andFentanyl | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Black | Orange | ||
| * Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| * Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| * Please note that following drugs have extremely low permeation times: | |||
| 1. Carmustine (BCNU) |
- Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Indications for Use
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 ( Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugsand Fentanyl | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Black | Orange | ||
| * Carmustine | 3.3mg/ml (3,300 ppm) | 21.6 | 22.7 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 50 mg/ml(500 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| * Thiotepa | 10 mg/ml (10,000 ppm) | 28 | 37.1 |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. | >240 min. |
| * Please note that following drugs have extremely low permeation times: |
1 . Carmustine ( BCNU)
- Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
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Summary of The Technological Characteristic
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange), are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Subject DeviceK232252 | Predicate DeviceK230121 | Remarks | |
|---|---|---|---|---|---|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same | |
| Intended Use | - | Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner | Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner | Same | |
| Design | - | Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff | Same | |
| Indications forUse | - | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.These gloves were tested foruse with ChemotherapyDrugs and Fentanyl Citrate asper ASTM D6978-05(Reapproved 2019) StandardPractice for Assessment ofMedical Gloves to Permeationby Chemotherapy Drugs. | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with ChemotherapyDrugs and Fentanyl Citrateas per ASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs. | Same | |
| Construction | - | Ambidextrous Chlorinated,Powder Free Nitrile | Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile | Similar | |
| Color Description | - | Black & Orange | Blue & Black | Different | |
| Material | - | Nitrile | Nitrile | Similar | |
| Single Use | - | Yes | Yes | Same | |
| Packaging | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same | |
| Chemo DrugsClaim | - | Chemo Drugs & FentanylCitrate claim | Chemo Drugs & FentanylCitrate claim | Similar | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Dimension | - | ||||
| LengthS, M, L, XL, XXL | ASTM D6319- 19 | Meet 220mm min for SMeet 230mm min for other sizes | Meet 220mm min for smallMeet 230mm min for other sizes | Similar | |
| Thickness (palm),Thickness (finger), | - | Meet 0.05mm minMeet 0.05mm min | Meet 0.05mm minMeet 0.05mm min | Similar | |
| Width | - | S: Meet $80 \pm 10$ mmM: Meet $95 \pm 10$ mmL: Meet $110 \pm 10$ mmXL: Meet $120 \pm 10$ mmXXL: Meet $130 \pm 10$ mm | S: Meet $80 \pm 10$ mmM: Meet $95 \pm 10$ mmL: Meet $110 \pm 10$ mmXL: Meet $120 \pm 10$ mm | Similar | |
| Characteristic | Standard | Subject DeviceK232252 | Predicate DeviceK230121 | Remarks | |
| Physical Properties | |||||
| (Before Ageing)i) Tensile Strength(MPa)ii) UltimateElongation (%) | ASTM D6319- 19 | Meet 14MPa min.Meet 500% min | Meet 14MPa min.Meet 500% min | Same | |
| (After Aging)i) Tensile Strength(MPa)ii) UltimateElongation (%)Water Leak Test, | Meets 14MPa minMeet 400% min. | Meets 14MPa minMeet 400% min. | Same | ||
| 1000 mlBefore Aging, AQL | ASTM D6319- 19ASTM D5151-19 | Passes at AQL 2.5Meet the ASTM D6319-19 requirement | Passes at AQL 1.5 | Different | |
| Powder FreeResiduePowder Free | ASTM D6319- 19ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max. | Same | |
| Residue, mg/ glove | |||||
| BiocompatibilityTest | |||||
| i) Primary SkinIrritation Test | ISO 10993-23 newversion(ISO 10993- 10) | PassesConclusion: The test resultshowed that the response ofthe test article wascategorized as negligibleunder the test condition | PassesConclusion: Under theconditions of this study thetest material did not cause anirritant response | Similar | |
| ii) Skin SensitizationTest | ISO 10993- 10 | PassesConclusion: Under theconditions of this study, the testarticle showed no significantevidence of causing skinsensitization in the guinea pig | PassesConclusion: Under theconditions of this study, thetest material did not produce askin sensitization effect | Similar | |
| iii) AcuteSystemic Toxicity | ISO 10993- 11 | Conclusion: Under theconditions of this study, therewas no evidence of acutesystemic toxicity from theextract. The test article extractmet the requirements of thestudy. | Conclusion: Under theconditions of this study, thetest material showed noadverse biological reactionafter administration of thesample's extract on the ratsduring the period of thestudy. | Similar | |
| Black color | |||||
| Test | Method | Acceptance Criteria | Result | ||
| Freedom FromHoles | ASTMD6319-19ASTMD5151-19 | Meet requirement inspection levelG- 1, AQL 2.5Sampling size125pcs(Ac: 7,Re: 8) | Pass≤3pcs | ||
| Dimension | ASTMD6319-19 | Length220 mm min (small)230 mm min (other sizes)Width(mm)S: 80±10M: 95±10L : 110±10XL : 120±10XXL : 130±10Thickness(mm):Palm: Minimum 0.05Finger: Minimum 0.05 | Pass241 mm minPassS: average 85.5mmM: average 96.3mmL: average 106.4mmXL: average 115.5mmXXL: average 125.1mmPassPalm - 0.178mm min.Finger-0.199mm min | ||
| Physicalproperties | ASTMD6319-19 | Before Aging:Tensile Strength: 14 MPa, min.Elongation: 500%, min.After Aging:Tensile Strength: 14 MPa, min.Elongation: 400%, min. | PassBefore Aging:Tensile Strength: 15.1 MPa, min.Elongation: 518%, min.After Aging:Tensile Strength: 15.0MPa, min.Elongation: 460%, min. | ||
| ResidualPowder Content | ASTMD6319-19ASTMD6124-06 | Not more than 2 mg per glove | Passaverage 0.32mg | ||
| Biocompatibilityi) Primary SkinIrritationii) SkinSensitizationiii) AcuteSystemicToxicity | ISO 10993-23ISO 10993-10ISO 10993-11 | Not a primary skin irritantNot a contact sensitizerNo systemic toxicity | PassPassPass | ||
| ChemotherapyDrug | Concentration | Minimum Breakthrough DetectionTime (minutes) | Remark |
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Summary of Non-Clinical Testing
Following is a table showing the actual measured parameters of the gloves (e.g length, thickness, physical properties, etc.) as compared to ASTM, EN and ISO. All data meets the standard reference requirement.
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DH Medical
| Orange color | |||
|---|---|---|---|
| Test | Method | Acceptance Criteria | Result |
| Freedom FromHoles | ASTMD6319-19ASTMD5151-19 | Meet requirement inspection levelG- 1, AQL 2.5Sampling size125pcs(Ac: 7,Re: 8) | Pass≤4pcs |
| Dimension | ASTMD6319-19 | Length220 mm min (small)230 mm min (other sizes)Width(mm)S: 80±10M: 95±10L : 110±10XL : 120±10XXL : 130±10Thickness(mm):Palm:Minimum 0.05Finger:Minimum 0.05 | Pass240 mm minPassS: average 85.8mmM: average 96.1mmL: average 106.8mmXL: average 115.9mmXXL: average 125.6mmPassPalm - 0.181mm min.Finger-0.212mm min |
| Physicalproperties | ASTMD6319-19 | Before Aging:Tensile Strength: 14 MPa, min.Elongation: 500%, min.After Aging:Tensile Strength: 14 MPa, min.Elongation: 400%, min. | PassBefore Aging:Tensile Strength: 15.3 MPa, min.Elongation: 502%, min.After Aging:Tensile Strength: 14.1MPa, min.Elongation: 462%, min. |
| ResidualPowder Content | ASTMD6319-19ASTMD6124-06 | Not more than 2 mg per glove | Passaverage 0.30mg |
| Biocompatibility | i) Primary SkinIrritation | ISO 10993-23Not a primary skin irritant | Pass |
| ii) SkinSensitization | ISO 10993-10Not a contact sensitizer | Pass | |
| iii) AcuteSystemicToxicity | ISO 10993-11No acute systemic toxicity | Pass | |
| Chemotherapy Drug andFentanyl | Concentration | Minimum Breakthrough DetectionTime (minutes) | Remark |
{10}------------------------------------------------
| Proposed Device | Predicate Device | |||||
|---|---|---|---|---|---|---|
| Black | Orange | Blue | Black | |||
| * Carmustine ( BCNU) | 3.3 mg/ml | 21.6 | 22.7 | 22.6 | 21.8 | Different |
| Cyclophosphamide | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Etoposide | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| * Thio Tepa | 10.0 mg/ml | 28 | 37.1 | 43.9 | 17.7 | Different |
| Mitomycin C | 0.5mg/ml | >240 min | >240 min | Not test | Not test | Different |
| Oxaliplatin | 5mg/ml | >240 min | >240 min | Not test | Not test | Different |
| Dacarbazine | 10.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Ifosfamide | 50.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Cisplatin | 1.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Mitoxantrone | 2 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Vincristine Sulfate | 1.0 mg/ml | Not test | Not test | >240 min | >240 min | Different |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min | >240 min | >240 min | Same |
| Warning | Please note that followingdrugs have extremely lowpermeation times: | *Please note that followingdrugs have extremely lowpermeation times: | Similar | |||
| 1. Carmustine (BCNU) (3.3 mg/ml) | 1. Carmustine (BCNU) (3.3 mg/ml) | |||||
| 2. Thio Tepa (10 mg/ml) | 2. Thio Tepa (10 mg/ml) |
Summary of Clinical Testing
Not applicable.
CONCLUSIONS
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, K230121,Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
§ 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.