(109 days)
Not Found
No
The device is a medical glove, which is a physical product and does not inherently contain any computational or AI models. The document describes its physical properties, testing standards, and performance metrics, with no mention of AI, DNN, or ML.
No
The device, examination gloves, is intended to prevent contamination between examiner and patient, not to treat or therapeutically affect an anatomical site or disease.
No
Explanation: The device is described as an examination glove intended to prevent contamination. Its function is to provide a barrier, not to identify or measure health conditions.
No
The device is a physical product (gloves) and has no software components. The summary focuses on physical properties, material standards, and biocompatibility, which are all characteristics of a hardware device.
No.
This device is an examination glove, used for preventing contamination between examiner and patient, and does not perform in vitro diagnostic testing on specimens derived from the human body.
N/A
Intended Use / Indications for Use
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Product codes
LYY
Device Description
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purpose
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 demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- ASTM D3578-19 Standard Specification for Rubber Examination Gloves
- ISO 2859-1 Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: S: >220mm, M-XXL:>230mm. Results: Small 285-290, Medium 285-294, Large 286-294, X-Large 286-290, XX-Large 296-299.
- Width: S: 80±10mm, M: 95±10mm, L: 111±10mm, XL: 120±10mm, XXL: 130±10mm. Results: Small 80-81, Medium 92-93, Large 103-105, X-Large 112-114, XX-Large 123-125.
- Thickness: Palm - >0.08mm, Finger- >0.08mm. Results (Palm, Finger in mm): Small 0.27-0.29, 0.33-0.39; Medium 0.28-0.31, 0.34-0.40; Large 0.27-0.29, 0.35-0.38; X-Large 0.26-0.28, 0.36-0.39; XX-Large 0.26-0.29, 0.33-0.35.
- Tensile strength (Before Aging >18MPa, After Aging >14MPa):
- Before Aging (MPa): Small 26.20, Medium 30.04, Large 29.91, X-Large 26.15, XX-Large 28.93
- After Aging (MPa): Small 26.77, Medium 24.89, Large 25.71, X-Large 23.43, XX-Large 25.86
- Ultimate elongation (Before Aging >650%, After Aging >500%):
- Before Aging (%): Small 850, Medium 853, Large 888, X-Large 893, XX-Large 833
- After Aging (%): Small 927, Medium 751, Large 790, X-Large 845, XX-Large 841
- Holes in gloves: AQL 2.5. Results: S – Pass AQL 2.5, M – Pass AQL 2.5, L – Pass AQL 2.5, XL – Pass AQL 2.5, XXL – Pass AQL 2.5.
- Residual powder in the gloves: ≤2.0mg/glove. Results (mg/glove): Small 0.24, Medium 0.38, Large 0.40, X-Large 0.54, XX-Large 0.60.
- Extractable protein in the gloves:
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 29, 2025
Comfort Rubber Gloves Industries Sdn. Bhd.
Sumathi Saravana Sami
RA Manager
Lot 821
Jalan Matang
Matang, Perak 34750
Malaysia
Re: K250069
Trade/Device Name: Powder Free Natural Rubber Latex Examination Gloves - Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LYY
Dated: March 26, 2025
Received: March 26, 2025
Dear Sumathi Saravana Sami:
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.
Page 2
K250069 - Sumathi Saravana Sami Page 2
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 Quality System (QS) 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250069 - Sumathi Saravana Sami Page 3
assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K250069
Device Name
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Indications for Use (Describe)
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
510(k) SUMMARY
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Page 1 of 9
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
1.0 Submitter
Name: Comfort Rubber Gloves Industries Sdn. Bhd.
Address: Lot 821, Jalan Matang, 34750 Matang, Perak Malaysia
Phone No: 605-847 2777
Fax No: 605-847 9108
Contact Person: Sumathi d/o Saravana Sami (Miss.)
Designation: Regulatory Affair Manager
Email: s.sumathi@comfortrubber.com
Date of Preparation: 26th April 2025
2.0 Name of Device
Device Name: Powder Free Natural Rubber Latex Examination Gloves – Blue Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LYY)
Device Classification: Class I
510(K) Number: K250069
3.0 Predicate Device
Device Name: Blue Latex Examination Powder Free Gloves
Company: JR Engineering & medical Technologies (M) sdn. Bhd.
510(K) Number: K192329
Device Classification: Class I
Product Code: LYY
4.0 Description of the Device
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
5.0 Indication for Use of the Device
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Page 6
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Page 2 of 9
6.0 Summary of the Technological Characteristics of the Device
The technological characteristics of Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein are compared to the predicate device as shown in Table 1.
Table 1: Device General Comparison Table
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE (K192329) | SUBJECT DEVICE | COMPARISON | EXPLANATION |
|---|---|---|---|---|---|
| Manufacturer(s) | - | JR Engineering & medical Technologies (M) sdn. Bhd. | Comfort Rubber Gloves Industries Sdn. Bhd | - | - |
| Product Code | - | LYY | LYY | Same | - |
| Classification | - | Class I | Class I | Same | - |
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | - |
| Name of Device | - | Blue Latex Examination Powder Free Gloves | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein. | - | - |
| Indication for Use | - | Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. | Same | - |
| Material | ASTM D3578 – 19 | Natural Latex | Natural Rubber Latex | Same | - |
| Color | - | Blue | Blue | Same | - |
| Surface Appearance | - | Finger Textured | Finger Textured | Same | - |
Page 7
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE (K192329) | SUBJECT DEVICE | COMPARISON | EXPLANATION |
|---|---|---|---|---|---|
| Surface Treatment Powder/Powder Free | - | Powder Free | Powder Free | Same | - |
| Size | ASTM D3578 – 19 | Small, Medium, Large, Extra Large, Extra Extra Large | Small, Medium, Large, Extra Large, Extra Extra Large | Similar | - |
| Single use | Medical Glove Guidance Manual – Labelling | Single Use | Single Use | Same | - |
| Sterile/Non-Sterile | - | Non-Sterile | Non-Sterile | Same | - |
| Watertight Test (1000ml) | 21 CFR 800.20, ASTM D5151 – 19 | Pass AQL-2.5 | Pass AQL-2.5 | Same | - |
| Dimension - Length | ASTM D3578 – 19 | Length >230mm | Length>230mm | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Average Size Length:
- Small: 304 vs Small: 285-290
- Medium: 304 vs Medium: 285-294
- Large: 305 vs Large: 286-294
- X-Large: 305 vs X-Large: 286-290
- XX-Large: 305 vs XX-Large: 296-299
| Dimension - Width | ASTM D3578 – 19 | Width 95±10 mm (for Medium Size) | Width 95±5 mm (for Medium Size) | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Average Size Width:
- Small: 84 vs Small: 80-81
- Medium: 94 vs Medium: 92-93
- Large: 105 vs Large: 103-105
- X-Large: 114 vs X-Large: 112-114
- XX-Large: 123 vs XX-Large: 123-125
| Thickness | ASTM D3578 – 19 | Palm - >0.08mm, Finger- >0.08mm | Palm - >0.08mm, Finger- >0.08mm | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Palm (Actual Value) Finger (Actual Value):
- Small: 0.31, 0.38 vs Small: 0.27-0.29, 0.33-0.39
- Medium: 0.31, 0.38 vs Medium: 0.28-0.31, 0.34-0.40
- Large: 0.31, 0.38 vs Large: 0.27-0.29, 0.35-0.38
- X-Large: 0.31, 0.38 vs X-Large: 0.26-0.28, 0.36-0.39
- XX-Large: 0.31, 0.38 vs XX-Large: 0.26-0.29, 0.33-0.35
Page 8
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Page 3 of 9
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE (K192329) | SUBJECT DEVICE | COMPARISON | EXPLANATION |
|---|---|---|---|---|---|
| Physical Properties – Tensile Strength | ASTM D3578 – 19 | Before Aging Tensile Strength>18MPa | Before Aging Tensile Strength>18MPa | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Actual Value vs Size Tensile Strength (MPa):
- Small: 33.0 vs Small: 26.20
- Medium: 32.9 vs Medium: 30.04
- Large: 32.2 vs Large: 29.91
- X-Large: 31.9 vs X-Large: 26.15
- XX-Large: 31.1 vs XX-Large: 28.93
After Aging Tensile Strength>14MPa:
- Small: 30.0 vs Small: 26.77
- Medium: 30.6 vs Medium: 24.89
- Large: 29.9 vs Large: 25.71
- X-Large: 29.7 vs X-Large: 23.43
- XX-Large: 28.2 vs XX-Large: 25.86
| Physical Properties – Ultimate Elongation | ASTM D3578 – 19 | Before Aging Ultimate Elongation>650% | Before Aging Ultimate Elongation 650% Min | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Actual Value vs Size Elongation (%):
- Small: 1322 vs Small: 850
- Medium: 1250 vs Medium: 853
- Large: 1392 vs Large: 888
- X-Large: 1130 vs X-Large: 893
- XX-Large: 1149 vs XX-Large: 833
After Aging Ultimate Elongation>500%:
- Small: 1046 vs Small: 927
- Medium: 1122 vs Medium: 751
- Large: 1257 vs Large: 790
- X-Large: 1011 vs X-Large: 845
- XX-Large: 1110 vs XX-Large: 841
| Powder Residual Content | ASTM D6124-06 (2022) | ≤2.0mg/glove | ≤2.0mg/glove | Similar | Both the subject and predicate devices meet the same acceptance criteria. |
Size Residual Powder Content (mg/glove):
- Small: 0.20 vs Small: 0.24
- Medium: 0.21 vs Medium: 0.38
- Large: 0.22 vs Large: 0.40
- X-Large: 0.22 vs X-Large: 0.54
- XX-Large: 0.23 vs XX-Large: 0.60
Page 9
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Page 4 of 9
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE (K192329) | SUBJECT DEVICE | COMPARISON | EXPLANATION |
|---|---|---|---|---|---|
| Protein content | ASTM D5712 – 15 (2020) | Max 200µg/dm2 | 220mm M-XXL:>230mm | Size Length: Small 285-290, Medium 285-294, Large 286-294, X-Large 286-290, XX-Large 296-299 | |
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | To determine the width of the gloves | Width: S: 80±10mm M: 95±10mm L: 111±10mm XL: 120±10mm XXL: 130±10mm | Size Width: Small 80-81, Medium 92-93, Large 103-105, X-Large 112-114, XX-Large 123-125 | ||
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm - >0.08mm Finger- >0.08mm | Size Palm(mm) Finger(mm): Small 0.27-0.29 0.33-0.39, Medium 0.28-0.31 0.34-0.40, Large 0.27-0.29 0.35-0.38, X-Large 0.26-0.28 0.36-0.39, XX-Large 0.26-0.29 0.33-0.35 | ||
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | To determine the physical properties – Tensile strength | Before Aging Tensile Strength>18MPa After Aging Tensile Strength>14MPa | Size Before Aging After Aging: Small 26.20 26.77, Medium 30.04 24.89, Large 29.91 25.71, X-Large 26.15 23.43, XX-Large 28.93 25.86 | ||
| To determine the physical properties – Ultimate elongation | Before Aging Ultimate Elongation>650% After Aging Ultimate Elongation >500% | Size Before Aging After Aging: Small 850 927, Medium 853 751, Large 888 790, X-Large 893 845, XX-Large 833 841 | |||
| ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | S – Pass AQL 2.5, M – Pass AQL 2.5, L – Pass AQL 2.5, XL – Pass AQL 2.5, XXL – Pass AQL 2.5 |
Page 12
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Page 7 of 9
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | ≤2.0mg/glove | Size Residual Powder Content (mg/glove): Small 0.24, Medium 0.38, Large 0.40, X-Large 0.54, XX-Large 0.60 |
| ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method | To determine the extractable protein in the gloves |