CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)

K123116 · Worldmed Manufacturing Sdn. Bhd. · LZA · Feb 11, 2013 · General Hospital

Device Facts

• Record ID: K123116
• Device Name: CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
• Applicant: Worldmed Manufacturing Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Device Story

Single-use, disposable, black-colored nitrile examination gloves; worn on hands by healthcare personnel. Function as a physical barrier to prevent contamination between healthcare personnel and patients. Manufactured from nitrile latex; chlorinated to achieve powder-free status. Used in clinical or medical settings. No electronic or software components.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-10), watertightness (21 CFR 800.20), and physical property testing per ASTM D6319-10.

Technological Characteristics

Material: Nitrile latex. Form: Powder-free, chlorinated, black color. Standards: ASTM D6319-10 (dimensions, physical properties, thickness), ISO 10993-10 (biocompatibility), 21 CFR 800.20 (watertightness). Sterilization: Not specified (non-sterile). Connectivity: None.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use disposable glove to prevent cross-contamination between the wearer and the 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

• RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) (K112924)
• Non-Sterile, Powder-Free, Black Nitrile Examination Glove (K061553)

Submission Summary (Full Text)

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# K123116

### Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)

## Attachment 15

## 510(k) SUMMARY

## FEB 1 1 2013

#### Submitter : 1.0

| Name | : | Worldmed Manufacturing Sdn. Bhd. |
|----------------|---|------------------------------------------------------------------------------------------------------|
| Address | : | Lot 18873, Jalan Perusahaan 3,<br>Kamunting Industrial Estate,<br>34600 Taiping, Perak,<br>Malaysia. |
| Phone No. | : | 605-892 5555 |
| Fax No . | : | 605-829 5590 |
| Contact Person | : | Ooi Loon Seng (Madam) |

September 5, 2012 Date of Preparation :

#### 2.0 Name of the Device

Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)

| Common Name | : Patient Examination Gloves |
|-------------|------------------------------|
|-------------|------------------------------|

| Classification Name : | Patient Examination Gloves (CLASS I - 21CFR 880.6250) |
|-----------------------|-------------------------------------------------------|
|-----------------------|-------------------------------------------------------|

510(K) Number

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

Primary Predicate:

RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) Company : Riverstone Resources Sdn. Bhd. 510(K) : K112924

Additional Predicate:

Non-Sterile, Powder-Free, Black Nitrile Examination Glove Company : YTY Industry (Manjung) Sdn. Bhd. 510(K) : K061553

#### Description of the Device: 4.0

The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.

#### 5.0 Intended Use of the Device

The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

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

The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) are summarized with the following technological characteristics compared to ASTM Specification D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10 | Meets standard requirements |
| Physical Properties | ASTM D6319-10 | Meets standard requirements |
| Thickness | ASTM D6319-10 | Meets standard requirements |
| Biocompatibility | ISO 10993-10:2002/Amd<br>1:2006(E) Biological<br>evaluation of medical<br>devices - Part 10: Tests for<br>irritation and delayed-type<br>hypersensitivity<br>-<br>Amendment 1:2006-07-15<br>ISO 10993-10:2002/Amd<br>1:2006(E) Biological<br>evaluation of medical<br>devices - Part 10: Tests for<br>irritation and delayed-type<br>hypersensitivity<br>-<br>Amendment 1:2006-07-15 | Pass (Not a primary skin<br>irritant)<br>Pass (Not a contact sensitizer) |
| Watertight (1000ml) | 21 CFR 800.20 | Pass |

#### 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

#### Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0

Clinical data is not needed for gloves or most devices cleared by the 510(k) process.

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Attachment 15

#### 9.0 Substantial Equivalence Comparison

.

| Characteristic<br>and<br>parameters | Worldmed<br>Manufacturing<br>Sdn. Bhd. | Riverstone<br>Resources Sdn.<br>Bhd.<br>K112924 | YTY Industry<br>(Manjung) Sdn.<br>Bhd.<br>K061553 | Substantial<br>Equivalence<br>(SE) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | LZA | |
| Intended use | The Chlorinated<br>Powder Free Nitrile<br>Examination<br>Gloves (Black<br>Colour) is a single<br>use device<br>intended for<br>medical purposes<br>that is worn on the<br>hand of healthcare<br>and similar to<br>personnel prevent<br>contamination<br>between the<br>healthcare<br>personnel and the<br>patient. | RS BLACK Black<br>Nitrile Medical<br>Examination<br>Gloves Powder<br>Free (Non-Sterile)<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<br>device is for over-<br>the-counter use. | The Non-Sterile,<br>Powder-Free, Black<br>Nitrile Examination<br>Glove is a disposable<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | SE |
| Width<br>(Size Large) | Meets ASTM D<br>6319-10 (mm)<br>XS - 70 ± 10<br>S - 80 ± 10<br>M - 95 ± 10<br>L - 110 ± 10<br>XL-120 ± 10 | Meets ASTM D<br>6319-10 | Palm Width (mm)<br>Size XS: 73-78<br>S : 83-88<br>M : 93-98<br>L : 103-107 | SE |
| Overall length | Length ≥ 240mm | Meets ASTM D<br>6319-10 | 240mm minimum for<br>all sizes | SE |
| Palm thickness | Min 0.05mm | Meets ASTM D<br>6319-10 | Min 0.08 | SE |
| Finger<br>thickness | Min 0.05mm | Meets ASTM D<br>6319-10 | Min 0.08 | |
| Tensile<br>Strength before<br>aging min. | 14.0 MPa | Meets ASTM D<br>6319-10 | 15-21 MPa | |
| Tensile<br>Strength<br>after<br>aging min | 14.0 MPa | Meets ASTM D<br>6319-10 | 14-22 MPa | |
| Ultimate<br>elongation<br>before<br>aging<br>min | 500% | Meets ASTM D<br>6319-10 | 550 % - 630 % | |
| Ultimate<br>elongation after<br>aging | 400% | Meets ASTM D<br>6319-10 | 520 % - 610 % | |
| Meets<br>Biocompatibility | Yes | Yes | Yes | SE |
| Skin irritation | Passes | Passes | Passes | |
| Dermal<br>sensitization | Passes | Passes | Passes | |
| Residual<br>powder test | Passes - Below<br>2mg/glove | Meets ASTM D<br>6319-10 | Below 2 mg/glove | |
| Freedom from<br>Holes | Meets<br>Requirements per<br>21CFR800.20:<br>Gloves Free of<br>Holes at quality<br>level of AQL 1.5<br>(AQL 2.5 required<br>per standard) | Meets ASTM D<br>6319-10 | Multiple Normal GII<br>AQL=2.5 | Yes, SE |
| Materials | Nitrile Latex | Nitrile Latex<br>compound | - | Yes,<br>Substantial<br>Equivalence |

.

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## Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)

### Attachment 15

K123116

#### 10.0 Conclusion

Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) will perform according to the gloves performance standards referenced in section 6.0 above and meets ASTM standards and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.

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

## February 11, 2013

Ms. Ooi Loon Seng Regulatory Affairs Manager Worldmed Manufacturing Sdn. Bhd. Lot 18873, Jalan Perusahaan 3, Kamunting Industrial Estate Kamunting Perak, Malaysia 34600

Re: K123116

Trade/Device Name: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: September 24, 2012 Received: November 13, 2012

Dear Ms. Seng:

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.

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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 (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hoi

heth
Harshit.D.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)

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Attachment 2

## INDICATIONS FOR USE

Applicant

WORLDMED MANUFACTURING SDN. BHD. Lot 18873, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia.

510(k) Number (if known)

K123116

Device Name

CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)

Indications For Use

Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE )

| Prescription Use<br>Per 21 CFR 801.109 | | | OR Over-The-Counter | X |
|----------------------------------------------------------------------------------------------------------|---------|--|---------------------|---|
| Elizabeth F. Claverie | | | | |
| 2013.02.11 13:32:02-05'00' | | | | |
| (Division Sign-Off)<br>Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | | | | |
| 510(k) Number: | K123116 | | Page 1 of 1 | |