Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · LYY · Apr 29, 2025 · General Hospital

Device Facts

• Record ID: K250069
• Device Name: Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
• Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Disposable, non-sterile, natural rubber latex examination gloves; blue color; finger-textured surface; powder-free. Used in medical settings by clinicians to prevent cross-contamination between examiner and patient. Device acts as a physical barrier. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D3578-19 (physical properties, dimensions), ASTM D5151-19 (watertightness), ASTM D6124-06 (residual powder), and ASTM D5712-15 (protein content). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (systemic toxicity), and ISO 10993-23 (irritation).

Technological Characteristics

Material: Natural rubber latex. Surface: Finger-textured, powder-free. Dimensions: Length >230mm, various widths per size. Standards: ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15. Biocompatibility: ISO 10993-5, 10, 11, 23. Non-sterile. Single-use.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient.

Regulatory Classification

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.

Predicate Devices

• Blue Latex Examination Powder Free Gloves (K192329)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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-

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K250069 - Sumathi Saravana Sami
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 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 [e-mail] | |
| "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." | |

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein

# 510(k) SUMMARY

# K250069

# 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 | : | [e-mail] |
| 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 1 of 9

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein

# 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 | - |

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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 | Small | 285-290 |
| Medium | 304 | Medium | 285-294 |
| Large | 305 | Large | 286-294 |
| X-Large | 305 | X-Large | 286-290 |
| XX-Large | 305 | 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 | Small | 80-81 |
| Medium | 94 | Medium | 92-93 |
| Large | 105 | Large | 103-105 |
| X-Large | 114 | X-Large | 112-114 |
| XX-Large | 123 | 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) | Size | Palm (mm) | Finger (mm) |
| Small | 0.31 | 0.38 | Small | 0.27-0.29 | 0.33-0.39 |
| Medium | 0.31 | 0.38 | Medium | 0.28-0.31 | 0.34-0.40 |
| Large | 0.31 | 0.38 | Large | 0.27-0.29 | 0.35-0.38 |
| X-Large | 0.31 | 0.38 | X-Large | 0.26-0.28 | 0.36-0.39 |
| XX-Large | 0.31 | 0.38 | XX-Large | 0.26-0.29 | 0.33-0.35 |

Page 3 of 9

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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 |
| --- | --- | --- | --- | --- | --- |
| 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 | Size | Tensile Strength (MPa) |
| Small | 33.0 | Small | 26.20 |
| Medium | 32.9 | Medium | 30.04 |
| Large | 32.2 | Large | 29.91 |
| X-Large | 31.9 | X-Large | 26.15 |
| XX-Large | 31.1 | XX-Large | 28.93 |
| After Aging Tensile Strength>14MPa | After Aging Tensile Strength>14MPa |
| Size | Actual Value | Size | Tensile Strength (MPa) |
| Small | 30.0 | Small | 26.77 |
| Medium | 30.6 | Medium | 24.89 |
| Large | 29.9 | Large | 25.71 |
| X-Large | 29.7 | X-Large | 23.43 |
| XX-Large | 28.2 | 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 | Size | Elongation (%) |
| Small | 1322 | Small | 850 |
| Medium | 1250 | Medium | 853 |
| Large | 1392 | Large | 888 |
| X-Large | 1130 | X-Large | 893 |
| XX-Large | 1149 | XX-Large | 833 |
| After Aging Ultimate Elongation>500% | After Aging Ultimate Elongation>500% |
| Size | Actual Value | Size | Elongation (%) |
| Small | 1046 | Small | 927 |
| Medium | 1122 | Medium | 751 |
| Large | 1257 | Large | 790 |
| X-Large | 1011 | X-Large | 845 |
| XX-Large | 1110 | 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) | Size | Residual Powder Content (mg/glove) |
| Small | 0.20 | Small | 0.24 |
| Medium | 0.21 | Medium | 0.38 |
| Large | 0.22 | Large | 0.40 |
| X-Large | 0.22 | X-Large | 0.54 |
| XX-Large | 0.23 | XX-Large | 0.60 |

Page 4 of 9

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Protein content | ASTM D5712 – 15 (2020) | Max 200μg/dm² | | <50μg/dm² | | Similar | The subject device has a lower acceptance criterion to support a low protein claim. |
| | | Size | Protein Content (μg/dm²) | Size | Protein Content (μg/dm²) | | |
| | | Small | 45 | Small | 43.65 | | |
| | | Medium | 44 | Medium | 40.05 | | |
| | | Large | 44 | Large | 44.71 | | |
| | | X-Large | 43 | X-Large | 42.51 | | |
| | | XX-Large | 45 | XX-Large | 48.33 | | |
| Biocompatibility | Primary Skin Irritation (Predicate Device)
ISO 10993-10:2010(E)/Animal Irritation Test (Subject Device)
ISO 10993-23:2021
Biological evaluation of medical devices
Part 23: Tests for irritation | Under the conditions of study not an irritant | | Under the conditions of the study, not an irritant | | Same | - |
| | Dermal Sensitization Assay
ISO 10993-10:2021
Biological evaluation of medical devices
Part 10: Tests for skin sensitization | Under the conditions of the study, not a sensitizer | | Under the condition of this study, not a sensitizer. | | Same | - |

Page 5 of 9

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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 |
| --- | --- | --- | --- | --- | --- |
| Biocompatibility | In Vitro
Cytotoxicity
ISO 10993-5:2009
Biological evaluation of medical devices
Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, cytotoxic which is to be expected as latex is the positive control for this test. | Under the conditions of the study, exhibited cytotoxicity reactivity from 100.0% to 6.25% and no cytotoxicity reactivity at 3.125% extract concentrations. | Same | - |
| | Acute
Systemic Toxicity
ISO 10993-11:2017
Biological evaluation of medical devices
Part 11: Tests for systemic toxicity | No data provided | Under the condition of this study, the single dose acute systemic toxicity of extracts from test material using both normal saline and cottonseed oil, did not demonstrate any adverse toxic reaction. | Different | Acute systemic toxicity testing was conducted to address the in vitro cytotoxicity |
| Shelf Life | Medical Glove Guidance Manual | No data provided | 3 Years | Different | Does not impact substantial equivalence because the shelf life is determined by specific stability testing conducted under relevant conditions |
| Type of Use | 21 CFR Part 801 Subpart C – Labeling Requirements for Over-the-Counter Devices | Over the Counter (OTC) | Over the Counter (OTC) | Same | - |

Page 6 of 9

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein

7.0 Summary of Non-Clinical Performance Testing

| Test Method | Purpose | Acceptance Criteria | Result | | |
| --- | --- | --- | --- | --- | --- |
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | To determine the length of the gloves | Length: S: >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) |
| | | | Small | | 0.27-0.29 |
| | | | Medium | | 0.28-0.31 |
| | | | Large | | 0.27-0.29 |
| | | | X-Large | | 0.26-0.28 |
| | | | XX-Large | | 0.26-0.29 |
| 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 |
| | | | Small | | 26.20 |
| | | | Medium | | 30.04 |
| | | | Large | | 29.91 |
| | | | X-Large | | 26.15 |
| | | | XX-Large | | 28.93 |
| | To determine the physical properties – Ultimate elongation | Before Aging Ultimate Elongation>650% After Aging Ultimate Elongation >500% | Size | | Before Aging |
| | | | Small | | 850 |
| | | | Medium | | 853 |
| | | | Large | | 888 |
| | | | X-Large | | 893 |
| | | | XX-Large | | 833 |
| 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 | | |

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein

| 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 | <50μg/dm² | Size
Protein Content (μg/dm²) |
| | | | Small
43.65 |
| | | | Medium
40.05 |
| | | | Large
44.71 |
| | | | X-Large
42.51 |
| | | | XX-Large
48.33 |
| ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation | Assessment of medical devices and their constituent materials with regard to their potential to produce irritation | Non-irritating | Under the conditions of the study, not an irritant. |
| ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization | Assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization | Non-sensitizing | Under the condition of this study, not a sensitizer. |
| ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | To determine the biological response of mammalian cells in vitro using appropriate biological parameters | Non-cytotoxic | Under the conditions of the study, exhibited cytotoxicity reactivity from 100.0% to 6.25% and no cytotoxicity reactivity at 3.125% extract concentrations |
| ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity | Evaluation of the potential for medical device materials to cause adverse systemic reactions | No acute systemic toxicity | Under the condition of this study, the single dose acute systemic toxicity of extracts from test material using both normal saline and cottonseed oil, did not demonstrate any adverse toxic reaction. |

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

Page 8 of 9

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein

- 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

## 8.0 Clinical Performance Data

No clinical study is included in this submission.

## 9.0 Conclusion

The conclusion drawn from the nonclinical test demonstrate that the proposed device Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm² Or Less Protein is as safe, as effective, and performs as well as or better than the legally marketed predicate device, (K192329: Blue Latex Examination Powder Free Gloves).

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