Blue Latex Examination Powder Free Gloves

K192329 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LYY · Nov 25, 2019 · General Hospital

Device Facts

• Record ID: K192329
• Device Name: Blue Latex Examination Powder Free Gloves
• Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 25, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Blue Latex Examination Powder Free Gloves are disposable natural rubber latex gloves; blue color; powder-free; finger-textured. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Manufactured to meet ASTM D3578-05 (Reapproved 2015) standards. Non-sterile; single-use.

Clinical Evidence

Bench testing only. Performance evaluated against 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 performed per ISO 10993-10 (irritation, sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (pyrogenicity). All results met acceptance criteria.

Technological Characteristics

Material: Natural Rubber Latex. Dimensions: Length > 230 mm. Physical properties: Tensile strength > 18 MPa (before aging), > 14 MPa (after aging); Ultimate elongation > 650% (before aging), > 500% (after aging). Powder residue: ≤ 2 mg/glove. Standards: ASTM D3578-05, ASTM D5151-06, ASTM D6124-06, ASTM D5712-95. Biocompatibility: ISO 10993-5, 10993-10, 10993-11. Non-sterile, single-use.

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

• MCARE PF Powder-free Latex Examination Gloves (K141042)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 25, 2019

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K192329

Trade/Device Name: Blue 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 24, 2019 Received: August 27, 2019

Dear Manoj Zacharias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K192329

Device Name

Blue Latex Examination Powder Free Gloves

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <input type="checkbox"/> Residential Use - Part of STR 30A Subarea Plan <input checked="" type="checkbox"/> Owner - Time Construction with STR 30A Subarea Plan |

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510K SUMMARY K192329 as required by 21 CFR § 807.92

### A. APPLICANT INFORMATION

| Applicant | JR Engineering & Medical Technologies (M) SDN.BHD. |
|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Address | Lot 8 &10, Jalan Zurah 3, Lot 1 & 3, Jalan Zurah, 3A/1, Pusat<br>Perindustrian 2, 44200 Rasa, Selangor Darul Ehsan, Malaysia. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr.Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | November 24th 2019 |

#### B. DEVICE IDENTIFICATION

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

#### C. PREDICATE DEVICE

| Legally Marketed devices that<br>Equivalency is claimed | MCARE PF Powder-free Latex Examination Gloves |
|---------------------------------------------------------|-----------------------------------------------|
| 510 (K) Number | K141042 |
| Regulatory Class | Class I |
| Product code | LYY |

#### D. DESCRIPTION OF THE DEVICE:

Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.

{4}------------------------------------------------

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

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.

### F. TECHNOLOGICAL CHARACTERISTICS

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|--|---------|--|--|--|--|--|---------|
| | | PREDICATE | SUBJECT | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | --- | K141042 | K192329 | --- | | | | | | | | | | | | | | | | | | | | | | | | |
| Name of device | --- | MCARE PF<br>Powder Free<br>Latex<br>Examination<br>Gloves | Blue Latex Examination<br>Powder Free Gloves | --- | | | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions- Length | ASTMD3578-05<br>(Reapproved<br>2015) | Length > 230 mm | Length > 230 mm<br>Size Average Small 304 Medium 304 Large 305 X-Large 305 XX-Large 305 | | | | | | | | | | | | | Similar | | | | | | | | | | | | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | | K141042 K192329 | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical Properties-<br>Ultimate Elongation | ASTMD3578-05<br>(Reapproved 2015) | Before Ageing<br>Ultimate Elongation<br>> 650%<br>After Ageing<br>Ultimate Elongation<br>>500% | Before Ageing<br>Ultimate Elongation > 650%<br>Size Actual value Small 1322 Medium 1250 Large 1392 X-Large 1130 XX-Large 1149<br>After Ageing<br>Ultimate Elongation > 500%<br>Size Actual value Small 1046 Medium 1122 Large 1257 X-Large 1011 XX-Large 1110 | | | | | | | | | | | | | | | | | | | | | | | | | Similar |
| Dimensions- Width | ASTMD3578-05<br>(Reapproved<br>2015) | Width Min 95+/-<br>10 mm (for<br>medium size) | Width Min 95+/-10 mm<br>(for medium size)<br>Size Average Small 84 Medium 94 Large 105 X-Large 114 XX-Large 123 | | | | | | | | | | | | | Similar | | | | | | | | | | | | |
| Physical Properties-<br>Tensile Strength | ASTMD3578-05<br>(Reapproved<br>2015) | Before Ageing<br>Tensile Strength<br>> 18 Mpa_<br>After Ageing<br>Tensile Strength<br>> 14 Mpa | Before Ageing<br>Tensile Strength > 18 Mpa<br>Size Actual value Small 33.0 Medium 32.9 Large 32.2 X-Large 31.9 XX-Large 31.1<br>After Ageing<br>Tensile Strength > 14 Mpa Size Actual value Small 30.0 Medium 30.6 Large 29.9 X-Large 29.7 XX-Large 28.2 | | | | | | | | | | | | | | | | | | | | | | | | | Similar |
| 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) Small 0.31 0.38 Medium 0.31 0.38 Large 0.31 0.38 X-Large 0.31 0.38 XX-Large 0.31 0.38 | | | | | | | | | | | | | | | | | | | Similar | | | | | | |
| Powder Free Residue | ASTMDD6319-10<br>(Reapproved 2015) | $\leq$ 2 mg/glove | $\leq$ 2 mg/glove<br>Size Residual<br>powder content<br>(mg/glove) Small 0.20 Medium 0.21 Large 0.22 X-Large 0.22 XX-Large 0.23 | | | | | | | | | | | | | 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<br>cytotoxicity<br>ISO10993-5<br>:2009(E) | / | | Under the conditions of the<br>study, cytotoxic which is to be<br>expected as latex is the positive<br>control for this test. | Different | | | | | | | | | | | | | | | | | | | | | | | |
| | Material mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) / USP | Data Not available | | Under the conditions of the<br>study, non-pyrogenic | --- | | | | | | | | | | | | | | | | | | | | | | | |

{5}------------------------------------------------

{6}------------------------------------------------

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|-----------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | PREDICATE | CURRENT | |
| 510(k) Number | | K141042 | K192329 | |
| Water Tight (1000 ml) | ASTM D5151-06<br>(Reapproved 2015) | Passes | Passes AQL-2.5 | Same |
| Intended use | | The mCare Powder Free Latex<br>Examination Blue<br>Glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. | Blue Latex Examination<br>Powder Free Gloves are<br>disposable devices intended<br>for medical purpose that are<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and examiner. | Same |
| Material | | Natural Latex | Natural Latex | Identical |
| Color | | Blue | Blue | Identical |
| Texture | | Finger Texture | Finger texture | Identical |
| Size | ASTMD 3578-5<br>(Reapproved 2015) | Small, Medium,<br>Large, X Large &<br>XX Large | Small, Medium, Large, X<br>Large & XX Large | Same |
| Single Use | Medical Glove<br>Guidance Manual<br>- 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<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Meets FDA's label and<br>labeling requirements | Same |
| Manufacturer(s) | | Mercator Medical<br>(Thailand) LTD | JR Engineering & Medical<br>Technologies (M) SDN.BHD.<br>Malaysia | --- |

# G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result | |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ASTM D3578-05 (Reapproved<br>2015) Standard Specification<br>for Rubber Examination<br>Gloves | To determine the<br>length of the gloves | Min 230 mm for all sizes | Small:-304 mm<br>Medium:-304mm<br>Large:-305mm<br>X-Large:-305mm<br>XX-Large:-305 mm | |
| ASTM D3578-05 (Reapproved<br>2015) Standard Specification<br>for Rubber Examination<br>Gloves | To determine the<br>width of the gloves | Small:-80+/-6 mm<br>Medium:-95+/-6mm<br>Large:-105+/-6 mm<br>X-Large:-114+/-6 mm<br>XX-Large:-120 +/-6 mm | Small:-84 mm<br>Medium:-94 mm<br>Large:-105 mm<br>X-Large:-114 mm<br>XX-Large:-123 mm | |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm 0.08 mm min<br>Finger 0.08 mm min for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Palm Finger<br>0.31mm 0.38mm<br>0.31mm 0.38mm<br>0.31mm 0.38mm<br>0.31mm 0.38mm<br>0.31mm 0.38mm |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Tensile strength | Before Ageing Tensile Strength 18Mpa Min for all sizes<br>After Ageing Tensile Strength 14Mpa Min for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Before ageing After ageing<br>33Mpa 30Mpa<br>32.9Mpa 30.6Mpa<br>32.2Mpa 29.9Mpa<br>31.9Mpa 29.7Mpa<br>31.1Mpa 28.2Mpa |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Ultimate Elongation | Before Ageing Ultimate Elongation 650% Min for all sizes<br>After Ageing Ultimate Elongation 500% Min for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Before ageing After ageing<br>1322% 1046%<br>1250% 1122%<br>1392% 1257%<br>1130% 1011%<br>1149% 1110% |
| | To Determine the physical properties-stress at 500% Elongation | Before Ageing 5.5 Mpa Max for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Before ageing NA<br>5.1 Mpa<br>5.2 Mpa<br>5.2 Mpa<br>5.1 Mpa<br>5.2 Mpa |
| ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Residual Powder Content<br>0.20 mg/glove<br>0.21 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.23 mg/glove |
| ASTM D 5712-95 ( Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber | To determine the extractable protein in the gloves. | 200 µg/ dm² Max for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | Extractable Protein content<br>45 µg/ dm²<br>44 µg/ dm²<br>44 µg/ dm²<br>43 µg/ dm²<br>45 µg/ dm² |

{7}------------------------------------------------

{8}------------------------------------------------

The performance test data of the non-clinical tests meet following standards: ASTMD 3578-5 (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 D 5712-95 ( Re approved 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 K 192329, Blue Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K141042.