(393 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 Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
This document describes the premarket notification (510(k)) for the Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant. The focus of the study is on the non-clinical performance testing of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against several standards, including ASTM D6319, ASTM D6124, ASTM D412, ASTM D3767, ASTM D5151, and ASTM D6978, as well as ISO 10993 for biocompatibility.
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers-Tension) | Tensile Strength: Min 14.0 MPa; Ultimate Elongation: Min 400% (After Aging) | Tensile Strength: Min 14.0 MPa (Before Aging); 14MPa min (After Aging); Ultimate Elongation: Min 500% (Before Aging); 400% min (After Aging) |
| Dimensions | ASTM D3767 (Measurement of Dimensions) | Length (all sizes): Min 240 mm; Width (XS: ≤ 80 mm, S: 80 ± 10, M: 95 ± 10, L: 110 ± 10, XL: ≥ 110); Thickness (Finger: Min 0.05 mm, Palm: Min 0.05 mm, Cuff: Min 0.05 mm) | All dimensions passed, consistent with the minimum requirements. |
| Powder Free | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove | Less than 2 mg per glove |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 500 pcs; Inspection level: G1; AQL: 1.5, Acceptance No. 10 | Inspection level: G1; AQL: 1.5, Found 2 (within acceptance criteria) |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Re-approved 2013) (Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection time for various drugs | Carmustine (BCNU): 21.2 minutes; Thiotepa: 34.6 minutes; Others (>240 minutes for Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Vincristine Sulfate) |
| Fentanyl Resistance | ASTM D6978 | Breakthrough detection time for Fentanyl Citrate Injection | No breakthrough up to 240 minutes |
| Primary Skin Irritation | ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16. Chapter II, Part 1500 | Non Irritating | Passes (Not a primary skin irritant, PII "0") |
| Dermal Sensitization | ISO 10993-10: 2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4) | Non Sensitization | Passes (Not a contact sensitizer) |
| Cytotoxicity | ISO 10993-5: 2009 (E) | Non Cytotoxic | Acute systemic toxicity testing performed to demonstrate safety (Different from predicate which was Non Cytotoxic). |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No systemic toxicity | Concluded that the product did not induce any systemic toxicity. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document primarily describes non-clinical testing.
- For the watertight test, the sample size used was 500 pieces.
- Specific sample sizes for other tests like physical properties, dimensions, residual powder, and biocompatibility are not explicitly stated in quantity, but imply a representative sample was tested to meet the ASTM and ISO standards.
- The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, WRP Asia Pacific Sdn Bhd, based in Malaysia. The studies are prospective as they are testing the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical performance testing of medical gloves against established engineering and biological standards, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the specific test methods and their measurable endpoints (e.g., breakthrough time, tensile strength values).
4. Adjudication Method for the Test Set
This information is not applicable as the document describes non-clinical performance testing against objective standards, not subjective assessments requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable. The device is a medical glove, and no algorithm or AI component is involved.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on established industry standards and regulatory requirements, including:
- ASTM standards (e.g., ASTM D412, D3767, D5151, D6124, D6978) for physical properties, dimensions, watertight integrity, residual powder, and chemical permeation.
- ISO 10993 standards for biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).
These standards define objective, measurable criteria for the glove's performance.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. Performance is evaluated against pre-defined, physical, and chemical standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable due to the absence of a training set for this device. The "ground truth" for evaluating the glove's performance is established by the methodologies and specified outcomes mandated by the referenced ASTM and ISO standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 4, 2022
WRP Asia Pacific SDN BHD % Saravanan Ramasamy HEAD of QARA Wrp Usa Inc 3700 Massillon Road. Suite 340 Uniontown, Ohio 44685
Re: K210330
Trade/Device Name: Dermagrip Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: February 8, 2022 Received: February 14, 2022
Dear Saravanan Ramasamy:
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
{1}------------------------------------------------
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 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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210330
Device Name
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVE, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE
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 Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Breakthrough Detection Time in Minutes |
|---|---|
| *Carmustine (BCNU) | 21.2 |
| Cisplatin | > 240 |
| Cyclophosphamide (Cytoxan) | > 240 |
| Dacarbazine | > 240 |
| Doxorubicin Hydrochloride | > 240 |
| Etoposide | > 240 |
| Fluorouracil | > 240 |
| Ifosfamide | > 240 |
| Methotraxate | > 240 |
| Mitomycin C | > 240 |
| Mitoxantrone | > 240 |
| Paclitaxel | > 240 |
| *Thiotepa | 34.6 |
| Vincristine Sulfate | > 240 |
- WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.
| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection | No breakthrough up to 240 minutes |
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
1.0 Submitter:
| Name: | Saravanan Ramasamy |
|---|---|
| Address: | WRP Asia Pacific Sdn BhdLot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 3 March 2022
2.0 Identification of the subject device:
: Dermagrip Powder Free Black Nitrile Patient Examination Trade Name Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance Common Name : Patient Examination Gloves Classification Name : Patient Examination Gloves Device Classification : 1 Regulation Number : 21 CFR 880.6250 Product Code
3.0 Predicate Device:
K183287
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Company: Kossan International Sdn. Bhd.
4.0 Description of The Device:
Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
5.0 Indication for use:
Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with fentanyl citrate.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
{4}------------------------------------------------
Chemotherapy Drug Permeation
The following chemicals have been tested for the glove.
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3mg/ml | 21.2 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 34.6 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.
| Fentanyl Resistant | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240minutes |
6.0 Summary of the Technological Characteristics of the Device:
Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.
{5}------------------------------------------------
| Table 1 | |||||
|---|---|---|---|---|---|
| DEVICE PERFORMANCE | |||||
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISONANALYSIS | |
| BLUE | DERMAGRIP POWDER FREE BLACKNITRILE PATIENT EXAMINATIONGLOVE, NON-STERILE, TESTED FORUSE WITH CHEMOTHERAPY DRUGSAND FENTANYL RESISTANCE | ||||
| 510(k) Number | - | K183287 | K210330 | ||
| Manufacturer(s) | - | Kossan International Sdn. Bhd. | WRP Asia Pacific | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | Blue | Black | Same | |
| Texture | - | Fingertips textured | Hand textured (Fully texturedsurface from fingertips to end ofpalm ) | Different | |
| Physical Properties | ASTM D6319 | Meets | Meets | ||
| Before AgingTensile Strength: | 28Mpa min | 14MPa min | Different but | ||
| Ultimate Elongation: | 500% min | 500% min | within the ASTMstandard | ||
| After AgingTensile Strength:Ultimate Elongation: | 30Mpa min480% min | 14MPa min400% min | Different butwithin the ASTMstandard | ||
| Thickness :- Finger- Palm- Cuff | ASTM D6319 | 0.10mm0.06mm0.04mm | 0.05mm min0.05mm min0.05mm min | Different butwithin the ASTMstandard | |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Same | |
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |||
| PREDICATE | SUBJECT DEVICE | ||||
| BLUE | DERMAGRIP POWDER FREE BLACKNITRILE PATIENT EXAMINATIONGLOVE, NON-STERILE, TESTED FORUSE WITH CHEMOTHERAPY DRUGSAND FENTANYL RESISTANCE | ||||
| Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Non Irritating | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test site after(24±2), (48±2) and (72±2)hours. The primary IrritationIndex (PII) was "0" | Similar | ||
| Biocompatibility | Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Non Sensitization | Passes (Not a contactsensitizer).There was no positive allergicreaction observed during thechallenge phase (at 0, 24hours and 48 hours) in animalstreated with the test materialand negative control. | Similar | |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Non Cytotoxic | Acute systemic toxicity testingperformed to demonstratesafety. | Different |
{6}------------------------------------------------
{7}------------------------------------------------
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | SUBJECT DEVICE | |||
| DERMAGRIP POWDER FREE BLACKNITRILE PATIENT EXAMINATIONGLOVE, NON-STERILE, TESTED FORUSE WITH CHEMOTHERAPY DRUGSAND FENTANYL RESISTANCE | ||||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Available | It is concluded that the productdid not induce any systemictoxicity. | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same |
| Intended use | - | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | Same |
| Size | Medical GloveGuidance Manual -Labeling | X SmallSmallMediumLargeExtra Large | X SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual -Labeling | Single use | Single use | Same |
{8}------------------------------------------------
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARD | PREDICATE | SUBJECT DEVICE | COMPARISON ANALYSIS |
| S | BLUE | DERMAGRIP POWDER FREE BLACKNITRILE PATIENT EXAMINATIONGLOVE, NON-STERILE, TESTED FORUSE WITH CHEMOTHERAPY DRUGSAND FENTANYL RESISTANCE | ||
| Chemotherapy Drugs | Minimum Breakthrough | Minimum Breakthrough | ||
| Permeation Test | Detection Time in Minutes | Detection Time in Minutes | ||
| Carmustine (BCNU) (3.3mg/ml) | 10.1 | 21.1 | Different | |
| Cisplatin (1.0mg/ml) | >240 | >240 | Same | |
| Cyclophosphamide (Cytoxan) (20.0mg/ml) | >240 | >240 | Same | |
| Cytarabine (100.0mg/ml) | >240 | Not Available | Different | |
| Dacarbazine (10.0mg/ml) | >240 | >240 | Same | |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 | >240 | Same | |
| Etoposide (Toposar) (20.0mg/ml) | >240 | >240 | Same | |
| Fluorouracil (50.0mg/ml) | ASTMD6978 | >240 | >240 | Same |
| Ifosfamide (50.0mg/ml) | >240 | >240 | Same | |
| Methotrexate (25.0mg/ml) | >240 | >240 | Same | |
| Mitoxantrone (2.0mg/ml) | >240 | >240 | Same | |
| Mitomycin C (0.5mg/ml) | >240 | >240 | Same | |
| Paclitaxel (Taxol) (6.0mg/ml) | >240 | >240 | Same | |
| *Thiotepa (10.0mg/ml) | 30.2 | 34.6 | Different | |
| Vincristine Sulfate (1.0mg/ml) | >240 | >240 | Same | |
| Warning Statement | Please note that Carmustine (BCNU)has extremely low permeation timesof 10.1 minutes | WARNING: Please note the followingdrugs have extremely low permeationtimes: Carmustine (BCNU): 21.1 minutesand Thiotepa: 34.6. Do not use withCarmustine and Thiotepa. | Different | |
| Fentanyl Resistant (100mcg/2ml) | ASTM D6978 | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | Same |
{9}------------------------------------------------
There are no significant differences between the two products and are identical in terms of intended use, materials design, manufacturing methods except for color, physical properties and thickness.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
{10}------------------------------------------------
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | |||
|---|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | Pass | Pass |
| Ultimateelongation | Min500% | Min400% | Pass | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | |
|---|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practice for | To measure thelength, width and | Length(all sizes) | Min 240 mm | Pass |
| Rubber- | thicknessof | Width | XS: ≤ 80 mm | Pass | |
| Measurement of | glove | S: 80 ± 10 | Pass | ||
| Dimensions | M: 95 ± 10 | Pass | |||
| L: 110 ± 10 | Pass | ||||
| XL: ≥ 110 | Pass | ||||
| Thickness(all sizes) | Finger: Min 0.05 mm | Pass | |||
| Palm: Min 0.05 mm | Pass | ||||
| Cuff: Min 0.05 mm | Pass |
{11}------------------------------------------------
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of theglove. | Sample size: 500 pcsInspection level: G1AQL: 1.5, Acceptance No. 10,Found 2 | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Pass |
{12}------------------------------------------------
8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject device (Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance) is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K183287.
§ 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.