Powder Free Nitrile Examination Gloves (Orange)

K171541 · Comfort Rubber Gloves Industries Sdn. Bhd. · LZA · Sep 20, 2017 · General Hospital

Device Facts

• Record ID: K171541
• Device Name: Powder Free Nitrile Examination Gloves (Orange)
• Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Examination Gloves (Orange) 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 nitrile examination gloves; worn on examiner's hand or finger; barrier protection to prevent cross-contamination between examiner and patient. Non-sterile; single-use. Used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data.

Technological Characteristics

Material: Nitrile. Standards: ASTM D6319-10(2015), ASTM D6124-06(2011), ISO 10993-10:2010, 21 CFR 800.20. Physical properties: Tensile strength min 14 MPa, elongation min 500% (before aging). Thickness: min 0.05mm (palm/finger). Powder content: ≤ 2 mg/glove. Watertight: AQL 2.5. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent 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

• Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile (K140418)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines forming a shape that suggests a human figure or a stylized bird.

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

September 20, 2017

Comfort Rubber Gloves Industries Sdn. Bhd. Chan Men OA & OMS Manager Lot 821, Jalan Matang Matang, 34750 MY

Re: K171541

Trade/Device Name: Powder Free Nitrile Examination Gloves (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 29, 2017 Received: September 1, 2017

Dear Chan Men:

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, 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (DICE) 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" (21 CFR 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerelv.

# Tara A. Ryan -S

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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### Attachment 2

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

### 510(k) Number (if known)

K171541

### Device Name

Powder Free Nitrile Examination Gloves (Orange)

Indications for Use (Describe)

The Powder Free Nitrile Examination Gloves (Orange) 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.

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# 510(k) SUMMARY

# POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)

#### 1.0 Submitter :

| Name | : Comfort Rubber Gloves Industries Sdn. Bhd. |
|----------------|-------------------------------------------------------------------------|
| Address | : Lot 821, Jalan Matang,<br>34750 Matang, Perak, Malaysia.<br>Malaysia. |
| Phone No. | : 605-847 2777 |
| Fax No. | : 605-847 9108 |
| Contact Person | : Chan Yew Men (Mr.) |

Date of Preparation : September 8, 2017

#### 2.0 Name of the Device

Powder Free Nitrile Examination Gloves (Orange)

| Common Name : | Patient Examination Gloves |
|-------------------|------------------------------------------------------------------|
| Regulation Name : | Patient Examination Gloves (21 CFR 880.6250 product<br>code LZA) |
| Device Class : | Class I |
| 510(K) Number : | K171541 |

#### 3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

Device Name : Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile

Company : WRP Rubber Products Sdn. Bhd.

510(K) No. : K140418

#### 4.0 Description of the Device:

The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 5.0 Intended Use of the Device

The Powder Free Nitrile Examination Gloves (Oranqe) 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.

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#### Summary of the Technological Characteristics of the Device: 6.0

The Powder Free Nitrile Examination Gloves (Orange) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1 and Figure 1 on Location of thickness and length measurement.

## Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | | Predicate | Current | |
| Manufacturer(s) | | WRP<br>Rubber<br>Products<br>Sdn Bhd | Comfort Rubber<br>Gloves<br>Industries Sdn.<br>Bhd | N/A |
| 510(k) number | | K140418 | K171541 | N/A |
| Length | ASTM D6319 -<br>10(2015) | Length-Min 230mm<br>width - min 95 ± 10<br>mm | Length-Min<br>240mm<br>width - min 85<br>mm for medium<br>glove | Same |
| Physical Properties | ASTM D6319 -<br>10(2015) | Meets<br>Before Aging<br>Tensile Strength<br>min 14 MPa<br>Ultimate<br>Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 MPa<br>Ultimate<br>Elongation<br>Min 400% | Meets<br>Before Aging<br>Tensile Strength<br>Min 14 MPa<br>Ultimate<br>Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 MPa<br>Ultimate<br>Elongation<br>Min 400% | Same |
| Thickness - Finger<br>- Palm | ASTM D6319 -<br>10(2015) | Meets<br>Palm - Min<br>0.05mm<br>Finger - Min<br>0.05mm | Meets<br>Palm - Min<br>0.05mm<br>Finger - Min<br>0.05mm | Same |
| Powder Content | ASTM D6124 -<br>06(2011)<br>(≤ 2 mg/glove) | Meets<br>≤ 2 mg/glove | Meets<br>≤ 2 mg/glove | Same |
| Biocompatibility | Primary Skin<br>Irritation<br>ISO 10993-10:2010<br>Biological<br>evaluation of<br>medical devices --<br>Part 10: Tests for<br>irritation and skin | Under the<br>conditions of the<br>study, not an<br>irritant. | Passes<br>Under the<br>conditions of the<br>study, the<br>subject device is<br>non-irritating | Same |
| | sensitization | | | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | substantially<br>equivalent to<br>predicate |
| | | Predicate | Current | |
| | Dermal<br>Sensitization<br>ISO 10993-10:2010<br>Biological<br>evaluation<br>of<br>medical devices --<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Under the<br>conditions of the<br>study, not a<br>sensitizer. | Passes<br>Under the<br>conditions of the<br>study, the<br>subject device is<br>non-sensitizing | Same |
| Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151 | Passes<br>AQL 2.5 | Passes<br>AQL 2.5 | Same |
| Intended Use | - | A patient<br>examination glove<br>is a disposable<br>device 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. | The Powder<br>Free Nitrile<br>Examination<br>Gloves (Orange)<br>is a disposable<br>device intended<br>for medical<br>purpose that is<br>worn on the<br>examiner's hand<br>or finger to<br>prevent<br>contamination<br>between<br>examiner and<br>patient. | Same |
| Material | ASTM D6319 -<br>10(2015) | Nitrile | Nitrile | Similiar |
| Color | - | Blue | Orange | - |
| Size | Medical Glove<br>Guidance Manual -<br>Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small -<br>75mm±5mm<br>Small -<br>85mm±5mm<br>Medium -<br>95mm±5mm<br>Large -<br>105mm±5mm<br>Extra Large<br>-115mm±5mm<br>Double Extra<br>Large<br>> 120mm<br><br>Length-Min<br>240mm | Same |
| Single Use | Medical Glove<br>Guidance Manual -<br>Labeling | Single Use | Single Use | Same |

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#### 7.0 Non-Clinical Performance Data Conclusion:

The subject device and the predicate non-clinical testing results demonstrate that the devices are similar or the same for the following non-clinical testing endpoints: physical properties (same specifications for thickness and length), powder content, biocompatibility, and water tight test.

#### 8.0 Clinical Performance Data Conclusion:

NA

#### 9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the Powder Free Nitrile Examination Gloves (Orange) device is substantially equivalent to the predicate device K140418.