Latex Examination Powder Free Gloves

K211477 · Aspen Glove Sdn. Bhd. · LYY · Sep 20, 2021 · General Hospital

Device Facts

• Record ID: K211477
• Device Name: Latex Examination Powder Free Gloves
• Applicant: Aspen Glove Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 20, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Latex Examination Powder Free Gloves are disposable, non-sterile, natural rubber latex gloves. Designed for use by healthcare examiners to provide a barrier against cross-contamination between patient and examiner. The device is worn on the hands during clinical examinations. It functions as a physical barrier; no electronic or mechanical processing is involved. The device is manufactured to meet ASTM D3578-05 standards for physical properties, including tensile strength, elongation, and dimensions. It is provided as a powder-free product to minimize potential irritation or contamination. The device is intended for general medical examination settings.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ASTM D3578-05 (dimensions, physical properties), ASTM D5151-06 (water tightness/holes), ASTM D6124-06 (residual powder), and ASTM D5712-95 (extractable protein). Biocompatibility testing included ISO 10993-10 (skin irritation, dermal sensitization), ISO 10993-5 (cytotoxicity), ISO 10993-11 (material-mediated pyrogenicity, acute systemic toxicity), and USP <85> (bacterial endotoxin). All results met acceptance criteria.

Technological Characteristics

Material: Natural Rubber Latex. Form factor: Disposable, non-sterile, powder-free examination glove. Dimensions: Length > 230 mm; various widths per size. Standards: ASTM D3578-05 (Reapproved 2015), ASTM D5151-06, ASTM D6124-06, ASTM D5712-95. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. No electronic components, software, or energy sources.

Indications for Use

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

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

• JR Medic Powder free Latex Examination Gloves (K192329)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

September 20, 2021

Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Mangement Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504

Re: K211477

Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 16, 2021 Received: August 16, 2021

Dear Manoj Zacharias:

We have reviewed vour 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211477

#### Device Name

Latex Examination Powder Free Gloves

#### Indications for Use (Describe)

Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

| 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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## 510K SUMMARY

# As required by 21CFR§807.92(c)

## A. APPLICANT INFORMATION

| Applicant | Aspen Glove Sdn. Bhd. |
|----------------|----------------------------------------------------------------------------------|
| Address | Aspen House, 300, JLN Macalister,<br>10450 Georgetown, Pulau Pinang,<br>Malaysia |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017 -550 0577 |
| Contact Email | [e-mail] |
| Date Submitted | APRIL 25th, 2021 |

### B. DEVICE IDENTIFICATION

| Name of the device | Latex Examination Powder Free Gloves |
|--------------------------------------|--------------------------------------|
| Product proprietary or<br>trade name | AspenPro+ |
| Common or usual name | Latex Examination Powder Free Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

### C. PREDICATE DEVICE

| Legally Marketed devices<br>that Equivalency is claimed | JR Medic Powder free Latex Examination Gloves |
|---------------------------------------------------------|-----------------------------------------------|
| 510(K) Number | K192329 |
| Regulatory Class | Class I |
| Product code | LYY |

## D. DESCRIPTION OF THE DEVICE:

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.

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## E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

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.

# F. TECHNOLOGICAL CHARACTERISTICS

| Characteristics | Standards | Device Performance | | Comparison | | | | | | | | | | | | |
|------------------------------------------------|--------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|
| | | Predicate | Current | | | | | | | | | | | | | |
| 510(K) Number | --- | K192329 | K211477 | --- | | | | | | | | | | | | |
| Name of device | --- | JR MEDIC<br>Blue Latex<br>Examination<br>Powder Free<br>Gloves | Latex Examination<br>Powder Free Gloves | --- | | | | | | | | | | | | |
| Dimensions-<br>Length | ASTMD3578-05<br>(Reapproved<br>2015) | Length > 230 mm | Length > 230 mm | Similar | | | | | | | | | | | | |
| | | | Size Average X-Small 236 Small 236 Medium 242 Large 248 X-Large 252 | | | | | | | | | | | | | |
| Dimensions- Width | ASTMD3578-05<br>(Reapproved<br>2015) | Width Min 95+/-<br>10 mm (for<br>medium size) | Width Min 95+/-10<br>mm (for medium size) | Similar | | | | | | | | | | | | |
| | | | Size Average X-Small 76 Small 85 Medium 98 Large 106 X-Large 116 | | | | | | | | | | | | | |
| Physical<br>Properties-<br>Tensile<br>Strength | ASTMD3578-05<br>(Reapproved<br>2015) | Before Ageing<br>Tensile Strength<br>> 18 Mpa | Before Ageing<br>Tensile Strength > 18 Mpa | Similar | | | | | | | | | | | | |
| | | | Size Actual value X-Small 22.08 Small 22.16 Medium 22.22 Large 22.30 X-Large 22.32 | | | | | | | | | | | | | |
| | | After Ageing<br>Tensile<br>Strength<br>> 14 Mpa | After Ageing<br>Tensile Strength > 14 Mpa | Similar | | | | | | | | | | | | |
| | | | Size Actual value X-Small 18.50 Small 18.56 Medium 18.65 Large 18.74 X-Large 18.76 | | | | | | | | | | | | | |

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| Characteristics | Standards | Device Performance | | Comparison | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|--|---------|
| | | Predicate | Current | | | | | | | | | | | | | | | | | | | |
| 510(K) Number | | K192329 | | | | | | | | | | | | | | | | | | | | |
| Physical Properties-<br>Ultimate Elongation | ASTMD3578-05<br>(Reapproved 2015) | Before Ageing<br>Ultimate Elongation<br>> 650% | Before Ageing<br>Ultimate Elongation > 650%<br>Size Actual value X-Small 856 Small 868 Medium 874 Large 880 X-Large 882 | | | | | | | | | | | | | Similar | | | | | | |
| | | After Ageing<br>Ultimate Elongation<br>>500% | After Ageing<br>Ultimate Elongation > 500%<br>Size Actual value X-Small 842 Small 850 Medium 855 Large 860 X-Large 862 | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Thickness | ASTMD3578-05<br>(Reapproved 2015) | Palm > 0.08 mm<br>Finger > 0.08 mm | Palm > 0.08 mm<br>Finger > 0.08 mm<br>Size Palm<br>(Actual value) Finger<br>(Actual value) X-Small 0.12 0.14 Small 0.12 0.14 Medium 0.12 0.14 Large 0.12 0.14 X-Large 0.12 0.14 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Free Residue | ASTMDD 3578-10<br>(Reapproved 2015) | <2 mg/glove | <2 mg/glove<br>Size Residual powder content (mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | | | | | | | | | | | | | Similar | | | | | | |
| Biocompatibility | Primary Skin<br>Irritation-ISO<br>10993-10:2010(E) | Under the condition<br>of study, not an<br>irritant | Under the condition of study<br>not an irritant | Same | | | | | | | | | | | | | | | | | | |
| | Dermal<br>Sensitization-ISO<br>10993-10:2010(E) | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of the<br>study, not a sensitizer | Same | | | | | | | | | | | | | | | | | | |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions<br>of the study,<br>non-cytotoxic | Under the conditions of the<br>study, non-cytotoxic | Same | | | | | | | | | | | | | | | | | | |
| | Material mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) / USP | Under the<br>conditions of the<br>study non pyrogenic | Under the conditions of the<br>study, non-pyrogenic | Same | | | | | | | | | | | | | | | | | | |

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| Characteristics | Standards | Device Performance Predicate | Current | Comparison |
|-----------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | | | |
| 510(K) Number | | K192329 | | ---- |
| Biocompatibility | Bacterial Endotoxin test<br>USP 42<85> | No data available | <20EU/pair of gloves | ---- |
| | Acute Systemic Toxicity Test ISO 10993-11:2017(E) | Under the condition of study not systemic toxic | Under the conditions of study the device extracts do not pose a systemic toxicity concern | same |
| Water Tight (1000 ml) | ASTM D5151-06 (Reapproved 2015) | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use | | JR MEDIC Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are won on the examiner's hand to prevent contamination between patient and examiner. | Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are won on the examiner's hand to prevent contamination between patient and examiner. | Same |
| Material | - | Natural Latex | Natural Latex | Identical |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Identical |
| Size | ASTMD 3578-5 (Reapproved 2015) | Small, Medium, Large & X Large | X Small, Small, Medium, Large, X-Large | Similar |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non Sterile | Non Sterile | Same |
| Powder/Powder free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label requirements | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same |
| Manufacturer(s) | - | JR Engineering & Medical Technologies (M) SDN BHD | Aspen Glove Sdn. Bhd. | --- |

# G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|--------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| ASTM D3578-05 (Reapproved 2015)<br>Standard Specification for Rubber<br>Examination Gloves | To determine the length of<br>the gloves | Min 230 mm for all sizes | X-Small 236 mm<br>Small 236 mm<br>Medium 242 mm<br>Large 248 mm<br>X-Large 252 mm |
| ASTM D3578-05 (Reapproved 2015)<br>Standard Specification for Rubber<br>Examination Gloves | To determine the width of<br>the gloves | X-Small 70+/-10 mm<br>Small 80+/-10mm<br>Medium 95+/-10 mm<br>Large 111+/-10 mm<br>X-Large 115+/-10 mm | X-Small 76 mm<br>Small 85 mm<br>Medium 98 mm<br>Large 106 mm<br>X-Large 116 mm |

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| Test Method | Purpose | Acceptance Criteria | Result | | |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| ASTM<br>D3578-05<br>(Reapproved 2015) Standard<br>Specification for Rubber<br>Examination Gloves | To determine the thickness of<br>the gloves | Palm 0.08 mm min<br>Finger 0.08 mm min<br>for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm     Finger<br>0.12mm   0.14mm<br>0.12mm   0.14mm<br>0.12mm   0.14mm<br>0.12mm   0.14mm<br>0.12mm   0.14mm | |
| ASTM<br>D3578-05<br>(Reapproved 2015) Standard<br>Specification for Rubber<br>Examination Gloves | To Determine the physical<br>properties-Tensile strength | Before Ageing<br>Tensile Strength<br>18Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing     After<br>ageing<br>22.08 Mpa   18.50 Mpa<br>22.16 Mpa   18.56 Mpa<br>22.22 Mpa   18.65 Mpa<br>22.30 Mpa   18.74 Mpa<br>22.32 Mpa   18.76 Mpa | |
| ASTM<br>D3578-05<br>(Reapproved 2015) Standard<br>Specification for Rubber<br>Examination Gloves | To Determine the physical<br>properties-Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>650% Min for all<br>sizes<br>After Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing     After<br>ageing<br>856%          842%<br>868%          850%<br>874%          855%<br>880%          860%<br>882%          862% | |
| | To Determine the physical<br>properties-stress at 500%<br>Elongation | Before Ageing<br>5.5 Mpa Max for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>5.1 Mpa<br>5.1 Mpa<br>5.2 Mpa<br>5.2 Mpa<br>5.2 Mpa | NA |
| ASTM<br>D5151-06<br>(Reapproved 2015) Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the holes in the<br>gloves | AQL 2.5 | Gloves Passes AQL 1.5 | | |
| ASTM<br>D6124-06<br>(Reapproved 2017) Standard<br>Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 Mg/Glove Max | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Residual Powder<br>Content<br>0.21 mg/glove<br>0.21 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove | |
| ASTM D5712-95 ( Re<br>approved 2010) Standard Test<br>Method for the Analysis of<br>Protein in Natural Rubber | To determine the extractable<br>protein in the gloves. | 200 µg/ dm² Max for<br>all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Extractable<br>Protein content<br>32 µg/ dm²<br>32 µg/ dm²<br>32 µg/ dm²<br>32 µg/ dm²<br>32 µg/ dm² | |

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## The performance test data of the non-clinical tests meet following standards:

- > ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
- > ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
- > ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- > ASTM D5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

## H. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K192329.