LATEX EXAMINATION GLOVE POWDER FREE

K161833 · Careglove Global Sdn. Bhd. · LYY · May 23, 2017 · General Hospital

Device Facts

• Record ID: K161833
• Device Name: LATEX EXAMINATION GLOVE POWDER FREE
• Applicant: Careglove Global Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: May 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable latex examination glove; powder-free; manufactured via on-line polymer coating and mild chlorination to modify surface characteristics for tack-free donning. Used in clinical settings by healthcare professionals to provide a protective barrier; prevents contamination between patient and examiner. Device is non-sterile; intended for single use.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing per ASTM D3578-05 and biocompatibility testing (primary skin irritation and sensitization) per ISO 10993-10.

Technological Characteristics

Material: Latex. Powder-free via on-line polymer coating and mild chlorination. Dimensions and physical properties (tensile strength, elongation) comply with ASTM D3578-05. Biocompatibility per ISO 10993-10. Protein content meets ASTM D5712-10 (≤50 µg/dm²). Residual powder content ≤2 mg/glove per ASTM D3578-05.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-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

• K152593

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

Careglove Global SDN BHD Lim Kwee Shyan Managing Director Lot 17479, Lrg Senawang 3/2 Off Jln Senawang 3 Senawang In Seremban, Negeri Sembilan, 70450 MY

Re: K161833

Trade/Device Name: Latex Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 25, 2017 Received: April 28, 2017

Dear Lim Kwee Shyan:

This letter corrects our substantially equivalent letter of May 23, 2017.

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K161833 |
| Device Name | LATEX EXAMINATION GLOVES POWDER FREE |
| Indications for Use (Describe) | A 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. |

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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Image /page/3/Picture/0 description: The image shows a logo for a company called "CARE GLOVE." The word "CARE" is written in large, bold, blue letters on top. Below it, the word "GLOVE" is written in a lighter green color. There is a blue circle with a light green handprint inside it, placed in the middle of the word "GLOVE." Underneath the words "CARE GLOVE," the text "CAREPLUS-DESCARPACK" is written in smaller, dark blue letters.

REGLOVE GLOBAL

Senawang 3/2. Off Jalan Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Ma Fax: [phone]

# K161833 510(K) SUMMARY

#### CAREGLOVE GLOBAL SDN BHD Applicant:

- Lot 17479, Lorong Senawang 2/3 Location Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377

Contact Person: Lim Kwee Shyan

Summary Preparation Date: 17th May, 2017

#### Device Information

LATEX EXAMINATION GLOVES POWDER FREE Trade Name:

Common Name: LATEX EXAMINATION GLOVES POWDER FREE

- Classification Name: Patient Examination Gloves
Product Code: Latex – LYY

Regulation Number: 21 CFR 880.6250.

### Device Description

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

### Intended Use of Device

A 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.

### Brief Description of Non-Clinical Test

Testing performed as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20. The subject device meet all the ASTM D3578-05 requirements. Primary skin irritation testing in the rabbit and Closed patch sensitization testing in the guinea pig were conducted in accordance with ISO 10993-10 indicate no irritation or sensitization.

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Image /page/4/Picture/0 description: The image shows a logo for a company called "Care Glove". The word "CARE" is in large, bold, blue letters on top. Below it, the word "GLOVE" is in a lighter green color, with a light green handprint inside the "O". Underneath that, the words "CAREPLUS-DESCARPACK" are in smaller, red letters.

CAREGLOVE GLOBAL SDI Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: [phone] Fax: [phone] Email: [e-mail]

Non-clinical laboratory and animal based test indicate that the powder free latex examination glove meets all the performance and biocompatibility requirements.

#### Summary of Technological Characteristic

Table 1; Comparison of Proposed and Predicate Device

| Parameter | ASTM<br>Specifications | Standard<br>References | Subject Device Measured<br>Values, K161833 | | Predicate<br>Device,<br>K152593 |
|------------------------------|------------------------|------------------------|--------------------------------------------|-----------------------|---------------------------------|
| | | | Value | Status | |
| Dimension | | | | | |
| Length<br>(size:XSmall), mm | 220 min. | ASTM D 3578-<br>05 | 224mm-<br>236mm | Meet<br>Specification | Meet<br>Specification |
| Length<br>(size:Small), mm | 220 min | ASTM D 3578-<br>05 | 225mm –<br>240mm | Meet<br>Specification | Meet<br>Specification |
| Length (size:<br>Medium), mm | 230 min | ASTM D 3578-<br>05 | 235mm –<br>246mm | Meet<br>Specification | Meet<br>Specification |
| Length (size:<br>Large), mm | 230 min | ASTM D 3578-<br>05 | 235mm –<br>245mm | Meet<br>Specification | Meet<br>Specification |
| Length<br>(size:XLarge), mm | N/A | ASTM D 3578-<br>05 | N/A | N/A | N/A |
| Thickness (palm),<br>mm | 0.08min. | ASTM D 3578-<br>05 | 0.12mm-<br>0.14mm | Meet<br>Specification | Meet<br>Specification |
| Thickness (finger),<br>mm | 0.08 min. | ASTM D 3578-<br>05 | 0.15mm-<br>0.17mm | Meet<br>Specification | Meet<br>Specification |
| Width (size:<br>XSmall) | 70 ± 10 | ASTM D3578-<br>05 | 73mm - 75mm | Meet<br>Specification | Meet<br>Specification |
| Width (size: Small),<br>mm | 80 ± 10 | ASTM D3578-<br>05 | 82mm-87mm | Meet<br>Specification | Meet<br>Specification |
| Width (size:<br>Medium), mm | 95 ± 10 | ASTM D3578-<br>05 | 94mm- 97mm | Meet<br>Specification | Meet<br>Specification |
| Width (size: Large),<br>mm | 111 ± 10 | ASTM D3578-<br>05 | 102mm-<br>107mm | Meet<br>Specification | Meet<br>Specification |
| Width (Size:<br>XLarge) | N/A | ASTM D3578-<br>05 | N/A | N/A | N/A |

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Image /page/5/Picture/0 description: The image is a logo for a company called "Care Glove". The word "CARE" is written in large, bold, blue letters on top of the word "GLOVE", which is written in a lighter green color. In the middle of the word "GLOVE" is a blue circle with a light green hand in the center. Underneath the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in smaller, blue letters.

# CAREGLOVE GLOBAL S

Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: [phone] Fax: [phone] Email: [e-mail]

| Parameter | ASTM<br>Specifications | Standard<br>References | Subject Device Measured | | Predicate |
|-----------------------------------------|------------------------|------------------------|-------------------------|-----------------------|-------------------------|
| | | | Values | | Device |
| | | | K161833 | | K152593 |
| | | | Value | Status | |
| Physical Properties | | | | | |
| Tensile Strength,<br>Before Aging, MPa | 18 min. | ASTM D 3578-<br>05 | 21.18MPa-<br>26.17MPa | Meet<br>Specification | Meet<br>Specification |
| Stress at 500%<br>Elongation | 5.5 MPa max. | ASTM D 3578-<br>05 | 3.0MPa-<br>4.2MPa | Meet<br>Specification | Meet<br>Specification |
| Ultimate Elongation,<br>Before Aging, % | 650 min. | ASTM D 3578-<br>05 | 750.20%-<br>820.20% | Meet<br>Specification | Meet<br>Specification |
| Tensile Strength,<br>After Aging, Mpa | 14 min. | ASTM D 3578-<br>05 | 18.28MPa-<br>23.88MPa | Meet<br>Specification | Meet<br>Specification |
| Ultimate Elongation,<br>After Aging, % | 500 min. | ASTM D 3578-<br>05 | 550.40%-<br>700.50% | Meet<br>Specification | Meet<br>Specification |
| Water Leak Test, 1000 ml | | | | | |
| Before Aging, AQL | 2.5 | ASTM D 3578-<br>05 | 1.5 and below | Meet<br>Specification | 1.5 and below |
| After Aging, AQL | 2.5 | ASTM D 3578-<br>05 | 2.5 and below | Meet<br>Specification | 2.5 and below |
| Extractable Protein | | | | | |
| Water Extractable<br>Protein, µg/dm² | 50 µg/dm² | ASTM D 5712-<br>10 | 50 µg/dm² and<br>below | Meet<br>Specification | 50 µg/dm² and<br>below |
| Residual Powder Content | | | | | |
| Residual Powder<br>Content, mg/glove | 2 mg/glove<br>max. | ASTM D 3578-<br>05 | 2 mg/glove and<br>below | Meet<br>Specification | 2 mg/glove<br>and below |

# Summary of Clinical Testing

Not applicable.

# Conclusions.

The conclusions drawn from nonclinical tests demonstrate that the subject device is a safe, as effective, and performs as well as or better than the legally marketed predicate device, K152593.