(109 days)
Not Found
No
The device is a physical examination glove and the summary describes standard physical and chemical testing, not AI/ML capabilities.
No.
The device is an examination glove, acting as a barrier for protection, not for treating or curing a medical condition.
No
The device is a non-sterile disposable examination glove worn between patient and examiner. Its purpose is protective and not to diagnose any condition or disease.
No
The device is a physical examination glove made of nitrile latex, not a software program. The description focuses on material properties and physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner." This describes a barrier device used during physical examinations.
- Function: The primary function is to provide a barrier and protect against chemotherapy drugs. This is a physical barrier function, not a diagnostic function.
- No Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Testing: The testing mentioned (ASTM D6978-05) is for permeation by chemotherapy drugs, which relates to the protective barrier function, not diagnostic performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes
LZA, LZC, OPJ
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable single-use, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the subject device meets all design specifications.
Test: Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-19
Purpose: To demonstrate glove integrity
Criteria: Freedom from holes AQL 1.5%
Result: Pass
Test: Standard Test Method for Residual Powder on Medical Gloves ASTM D6124-06(R17)
Purpose: To demonstrate the gloves are 'powder free'
Criteria: Average less than 2 mg/glove
Result: Pass
Test: Dimensional Conformance ASTM D6319
Purpose: To demonstrate appropriate dimensions for labeled sizes
Criteria: Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL AQL 4%
Result: Pass
Test: Tensile Performance ASTM D6319
Purpose: To demonstrate adequate tensile properties
Criteria: Conforms to ASTM D6319 tensile strength of at least 14MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14MPa and ultimate strength of at least 400% after accelerated aging AQL 4%
Result: Pass
Test: Biocompatibility: Skin Irritation ISO 10993-10
Purpose: To demonstrate low potential for skin irritation
Criteria: Under the conditions of the study, not an irritant.
Result: Pass
Test: Biocompatibility: Skin Sensitization ISO 10993-10
Purpose: To demonstrate low potential for skin sensitization
Criteria: Under the conditions of the study, not a sensitizer
Result: Pass
Test: Biocompatibility: Acute Toxicity ISO 10993-11
Purpose: To demonstrate low acute toxicity
Criteria: Under the conditions of the study, no acute toxicity
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
November 11, 2022
Hartalega NGC Sdn. Bhd. Nurul Kong General Manager-Ouality Assurance No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia
Re: K222225
Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: August 9, 2022 Received: August 17, 2022
Dear Nurul Kong:
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.
1
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.
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 Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K22225
Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | >240 |
| Bortezomib, 1.0 mg/ml | >240 |
| Busulfan, 6.0 mg/ml | >240 |
| Carboplatin, 10.0 mg/ml | >240 |
| Chloroquine, 50.0 mg/ml | >240 |
| Cyclosporin A, 100.0 mg/ml | >240 |
| Cytarabine, 100.0 mg/ml | >240 |
| Daunorubicin, 5.0 mg/ml | >240 |
| Docetaxel, 10.0 mg/ml | >240 |
| Epirubicin, 2.0 mg/ml | >240 |
| Fludarabine, 25.0 mg/ml | >240 |
| Gemcitabine, 38.0 mg/ml | >240 |
| Idarubicin, 1.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Irinotecan, 20.0 mg/ml | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | >240 |
| Melphalan, 5.0 mg/ml | >240 |
| Mitoxantrone, 2.0 mg/ml | >240 |
| Oxaliplatin, 2.0 mg/ml | >240 |
| Paraplatin, 10.0 mg/ml | >240 |
| Retrovir, 10.0 mg/ml | >240 |
| Rituximab, 10.0 mg/ml | >240 |
| Topotecan, 1.0 mg/ml | >240 |
3
| Trisenox, 1.0 mg/ml |
|---|
| --------------------- |
240
Caution: Testing showed an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
K222225
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
1. SUBMISSION APPLICANT
1
| Date Prepared | : | November 10, 2022 |
|---|---|---|
| Name | : | Hartalega NGC Sdn. Bhd. |
| Address | : | No. 1, Persiaran Tanjung, |
| Kawasan Perindustrian Tanjung, | ||
| 43900 Sepang, Selangor, | ||
| Malaysia | ||
| Establishment Registration | ||
| Number | : | 3011200663 |
SUBMISSION CORRESPONDENT AND/OR PREPARER
| Contact Name : | Nurul Aisyah Kong |
|---|---|
| Contact Title : | General Manager – Quality Assurance |
| Phone Number : | (603) 3280 3888 |
| Fax Number : | (603) 3271 0135 |
| Contact Email : | wkkong@hartalega.com.my |
2. DEVICE IDENTIFICATION
| Common Name of the Device | : | Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
5
3. PREDICATE DEVICE INFORMATION
| 510(k)
Number | Tradename | Product
Code |
|-------------------------------|------------------------------------------------------------------------------------------------------|-----------------|
| K151997 | Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drugs - Violet Blue (VBLU) | LZA |
| Regulation Name | Patient Examination Glove | |
| Trade Name (Proprietary Name) | Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drugs - Violet Blue (VBLU) | |
| Device Class | 1 | |
| Product Code | LZA | |
| Regulation Number | 21 CFR 880.6250 | |
4. DESCRIPTION OF THE DEVICE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
5. INDICATIONS FOR USE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in
Minutes |
|---------------------------------------|---------------------------------------------------|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
Hartalega NGC Sdn. Bhd.
6
| Thiotepa (10.0 mg/ml) | 30.2 |
|---|---|
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Bleomycin Sulfate, 15.0 mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 |
| Cyclosporin A, 100.0 mg/ml | > 240 |
| Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCl, 1.0 mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 |
| Retrovir, 10.0 mg/ml | > 240 |
| Rituximab, 10.0 mg/ml | > 240 |
| Topotecan, 1.0 mg/ml | > 240 |
| Trisenox, 1.0 mg/ml | > 240 |
Caution: Testing showed an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
6. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristics
| and Parameters | Subject Device | Predicate Device (K151997) | Discussion |
|---|---|---|---|
| Trade Name | Nitrile Powder Free Examination Glove | ||
| Tested for Use with Chemotherapy | |||
| Drugs (Blue) | Nitrile Powder Free Examination Gloves | ||
| Tested for Use with Chemotherapy Drugs | |||
| – Violet Blue (VBLU) | - | ||
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, OPJ | LZA | Similar |
| Classification | 1 | 1 | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
7
| Regulation Name | Patient Examination Glove | Patient Examination Glove | Same |
|---|---|---|---|
| Indications for Use | A non-sterile disposable device intended | ||
| for medical purpose that is worn on the | |||
| examiner's hand to prevent | |||
| contamination between patient and | |||
| examiner. It is also tested to be used | |||
| against Chemotherapy Drugs. | |||
| The gloves were tested for use with | |||
| chemotherapy drugs as per ASTM | |||
| D6978-05 (Reapproved 2019) Standard | |||
| Practice for Assessment of Resistance of | |||
| Medical Gloves to Permeation by | |||
| Chemotherapy Drugs. | A non-sterile disposable device intended | ||
| for medical purpose that is worn on the | |||
| examiner's hand to prevent | |||
| contamination between patient and | |||
| examiner. It is also tested to be used | |||
| against Chemotherapy Drugs. | |||
| The gloves were tested for use with | |||
| chemotherapy drugs as per ASTM D6978- | |||
| 05 (Reapproved 2019) Standard Practice | |||
| for Assessment of Resistance of Medical | |||
| Gloves to Permeation by Chemotherapy | |||
| Drugs. | Similar | ||
| Chemotherapy Drug | |||
| and Concentration | Chemotherapy Drug | ||
| and Concentration | |||
| Minimum Breakthrough | |||
| Detection Time | |||
| in Minutes | Minimum Breakthrough | ||
| Detection Time | |||
| in Minutes | |||
| Carmustine, 3.3 mg/ml 10.2 | Carmustine, 3.3 mg/ml 10.2 | ||
| Cisplatin, 1.0 mg/ml > 240 | Cisplatin, 1.0 mg/ml > 240 | ||
| Cyclophosphamide | |||
| (Cytoxan), 20.0 mg/ml > 240 | Cyclophosphamide | ||
| (Cytoxan), 20.0 mg/ml > 240 | |||
| Dacarbazine, 10.0 mg/ml > 240 | Dacarbazine, 10.0 mg/ml > 240 | ||
| Doxorubicin Hydrochloride, | |||
| 2.0 mg/ml > 240 | Doxorubicin Hydrochloride, | ||
| 2.0 mg/ml > 240 | |||
| Etoposide (Toposar), 20.0 | |||
| mg/ml > 240 | Etoposide (Toposar), 20.0 | ||
| mg/ml > 240 | |||
| Fluorouracil, 50.0 mg/ml > 240 | Fluorouracil, 50.0 mg/ml > 240 | ||
| Methotrexate, 25.0 mg/ml > 240 | Methotrexate, 25.0 mg/ml > 240 | ||
| Mitomycin C, 0.5 mg/ml > 240 | Mitomycin C, 0.5 mg/ml > 240 | ||
| Paclitaxel (Taxol), 6.0 mg/ml > 240 | Paclitaxel (Taxol), 6.0 mg/ml > 240 | ||
| Thiotepa, 10.0 mg/ml 30.2 | Thiotepa, 10.0 mg/ml 30.2 | ||
| Vincristine Sulfate, 1.0 mg/ml > 240 | Vincristine Sulfate, 1.0 mg/ml > 240 | ||
| Bleomycin Sulfate, 15.0 mg/ml > 240 | Caution: Testing showed an average | ||
| breakthrough time of 10.2 minutes with | |||
| Carmustine and 30.2 minutes with | |||
| Thiotepa. | |||
| Bortezomib, 1.0 mg/ml > 240 | Warning: Do not use with Carmustine and | ||
| Thiotepa | |||
| Busulfan, 6.0 mg/ml > 240 | |||
| Carboplatin, 10.0 mg/ml > 240 | |||
| Chloroquine, 50.0 mg/ml > 240 | |||
| Cyclosporin A, 100.0 mg/ml > 240 | |||
| Cytarabine, 100.0 mg/ml > 240 | |||
| Daunorubicin, 5.0 mg/ml > 240 | |||
| Docetaxel, 10.0 mg/ml > 240 | |||
| Epirubicin, 2.0 mg/ml > 240 | |||
| Fludarabine, 25.0 mg/ml > 240 | |||
| Gemcitabine, 38.0 mg/ml > 240 | |||
| Idarubicin, 1.0 mg/ml > 240 | |||
| Ifosfamide, 50.0 mg/ml > 240 | |||
| Irinotecan, 20.0 mg/ml > 240 | |||
| Mechlorethamine HCl, 1.0 mg/ml > 240 |
8
| | Melphalan, 5.0 mg/ml > 240
Mitoxantrone, 2.0 mg/ml > 240
Oxaliplatin, 2.0 mg/ml > 240
Paraplatin, 10.0 mg/ml > 240
Retrovir, 10.0 mg/ml > 240
Rituximab, 10.0 mg/ml > 240
Topotecan, 1.0 mg/ml > 240
Trisenox, 1.0 mg/ml > 240
Caution: Testing showed an average
breakthrough time of 10.2 minutes with
Carmustine and 30.2 minutes with
Thiotepa.
Warning: Do not use with Carmustine
and Thiotepa | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Type of use | Over the counter use | Over the counter use | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Freedom from
holes | Meets ASTM D5151-19 and ASTM D6319-
19: AQL 1.5 | Meets ASTM D5151-19 and ASTM D6319-
19: AQL 1.5 | Same |
| Length | Meets ASTM D6319-19:
$\geq$ 230 mm | Meets ASTM D6319-19:
$\geq$ 240 mm | Same |
| Dimensions | Meets ASTM D6319-19: XS - 70 ± 10 mm
S - 80 ± 10 mm
M - 95 ± 10 mm
L - 110 ± 10 mm
XL - 120 ± 10 mm | Meets ASTM D6319-19: XS - 70 ± 10 mm
S - 80 ± 10 mm
M - 95 ± 10 mm
L - 110 ± 10 mm
XL - 120 ± 10 mm | Same |
| Thickness | Meets ASTM D6319-19:
Palm Thickness: Min 0.05 mm Finger
Thickness: Min 0.05 mm | Meets ASTM D6319-19:
Palm Thickness: 0.08 ± 0.01 mm Finger
Thickness: $\geq$ 0.10 mm | Same |
| Physical
Properties | Meets ASTM D6319-19:
Tensile Strength Before Aging: $\geq$ 14 MPa
Tensile Strength After Aging: $\geq$ 14 MPa
Ultimate Elongation Before Aging: $\geq$ 500 %
Ultimate Elongation After Aging: $\geq$ 400 % | Meets ASTM D6319-19:
Tensile Strength Before Aging: $\geq$ 14 MPa
Tensile Strength After Aging: $\geq$ 14 MPa
Ultimate Elongation Before Aging: $\geq$ 500 %
Ultimate Elongation After Aging: $\geq$ 400 % | Same |
| Powder residual | Meets ASTM D6319-19 & ASTM D6124-
06 (2017):
Residual Powder: $\leq$ 2 mg per glove | Meets ASTM D6319-19 & ASTM D6124-06
(2017):
Residual Powder: $\leq$ 2 mg per glove | Same |
| Primary Skin
Irritation ISO
10993-10 | Under the conditions of the study, the
device is not an irritant | Under the conditions of the study, the
device not an irritant | Same |
| Dermal | Under the conditions of the study, the | Under the conditions of the study, the | Same |
| Sensitization
ISO 10993-10 | device is not a sensitizer | device not a sensitizer | |
| Acute Systemic
Toxicity Test ISO
10993-11 (2017) | Under the conditions of this study, the
device showed no evidence of acute
systemic toxicity | Not performed | Different |
9
7. SUMMARY OF NON-CLINICAL TESTING:
Non-clinical tests were conducted to verify that the subject device meets all design specifications.
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| Standard Test Method for | |||
| Detection of Holes in Medical | |||
| Gloves | |||
| ASTM D5151-19 | To demonstrate glove integrity | Freedom from holes | |
| AQL 1.5% | Pass | ||
| Standard Test Method for Residual | |||
| Powder on Medical Gloves | |||
| ASTM D6124-06(R17) | To demonstrate the gloves are | ||
| 'powder free' | Average less than 2 | ||
| mg/glove | Pass | ||
| Dimensional Conformance | |||
| ASTM D6319 | To demonstrate appropriate | ||
| dimensions for labeled sizes | Conforms to ASTM D6319 | ||
| width, thickness, and | |||
| length requirements for | |||
| XS, S, M, L, and XL | |||
| AQL 4% | Pass | ||
| Tensile Performance | |||
| ASTM D6319 | To demonstrate adequate tensile | ||
| properties | Conforms to ASTM D6319 | ||
| tensile strength of at least | |||
| 14MPa and ultimate | |||
| elongation of at least | |||
| 500% requirements prior | |||
| to aging, and tensile | |||
| strength of at least | |||
| 14MPa and ultimate | |||
| strength of at least 400% | |||
| after accelerated aging | |||
| AQL 4% | Pass | ||
| Biocompatibility: Skin Irritation | |||
| ISO 10993-10 | To demonstrate low potential for | ||
| skin irritation | Under the conditions of | ||
| the study, not an irritant. | Pass | ||
| Biocompatibility: Skin Sensitization | |||
| ISO 10993-10 | To demonstrate low potential for | ||
| skin sensitization | Under the conditions of | ||
| the study, not a sensitizer | Pass | ||
| Biocompatibility: | |||
| Acute Toxicity | |||
| ISO 10993-11 | To demonstrate low acute | ||
| toxicity | Under the conditions of | ||
| the study, no acute | |||
| toxicity | Pass |
CLINICAL PERFORMANCE DATA:
Not applicable. No clinical testing was performed in support of this submission.
CONCLUSION:
The conclusions drawn from the non-clinical performance data demonstrate that, the subject device, Nitrile
Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue), is as safe, as effective and performs as well as or better than the legally marketed predicate device K151997.
Hartalega NGC Sdn. Bhd.