K Number
K042805
Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
Date Cleared
2004-12-16

(65 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
Device Description
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
More Information

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Not Found

No
The summary describes a standard medical glove and makes no mention of AI or ML technology.

No
This device is a patient examination glove that provides a barrier against infectious materials and contaminants, and protects against chemotherapy drugs. It is not designed to treat or alleviate a disease or condition.

No

The device description indicates it is a glove for barrier protection and protection from chemotherapy drugs, not for diagnosing medical conditions.

No

The device is a physical glove, not software. The description focuses on material properties and performance against ASTM standards for physical characteristics and barrier protection.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is a "disposable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
  • Device Description: The description focuses on the physical properties and standards the glove meets (ASTM D 6319-00a83), which are relevant to barrier protection and material properties, not diagnostic testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to gain insights into a patient's health status. This glove serves a protective function for the user and the patient.

N/A

Intended Use / Indications for Use

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The glove may provide additional protection in other areas where users are handling certain hazardous chemicals such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

A Powder Free Nitrile Patient Examination Glove is a disposable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

Product codes (comma separated list FDA assigned to the subject device)

LZC

Device Description

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (for medical purposes)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
Dimensions: Meets ASTM D 6319-00aε,3
Physical Properties: Meets ASTM D 412-98
Freedom from pin-holes: Meets ASTM D 5151-99
Powder Free Residue: Meets ASTM D 6124-01
Biocompatibility: Dermal Sensitization (as per ASTM F-720-81) - Not a contact skin sensitizer
Primary Skin Irritation Test (as per 16 CFR Part 1500) - Not a primary skin irritant
Cytotoxicity Test (as per ISO 10993-5) - Non cytotoxic
Low Dermatitis Potential: Modified Draize Test - Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
Chemotherapy Drugs Permeation Test (ASTM F 739):
Carmustine (3.3 mg/mL) 137 minutes
Cisplatin (1.0 mg/mL) >240 minutes
Cyclophosphamide (20.0 mg/mL) >240 minutes
Dacarbazine (DTIC) (10.0 mg/mL) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/mL) >240 minutes
5-Fluorouracil (50.0 mg/mL) >240 minutes
Etoposide (20.0 mg/mL) >240 minutes
Paclitaxel (Taxol) (6.0 mg/mL) >240 minutes
Thio-Tepa (10.0 mg/mL) >240 minutes

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not a contact skin sensitizer
Not a primary skin irritant
Non cytotoxic
Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
Carmustine (3.3 mg/mL) 137 minutes
Cisplatin (1.0 mg/mL) >240 minutes
Cyclophosphamide (20.0 mg/mL) >240 minutes
Dacarbazine (DTIC) (10.0 mg/mL) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/mL) >240 minutes
5-Fluorouracil (50.0 mg/mL) >240 minutes
Etoposide (20.0 mg/mL) >240 minutes
Paclitaxel (Taxol) (6.0 mg/mL) >240 minutes
Thio-Tepa (10.0 mg/mL) >240 minutes

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

0

K042805

Attachment 4

Image /page/0/Picture/2 description: The image shows the letters "PGA" in white against a black background. The letters are in a bold, sans-serif font. The background is textured, giving the impression of a rough or grainy surface. The letters are slightly blurred, which could be due to the image quality or a stylistic choice.

EC 1 € 2004 ERUSAHAAN GETAH ASAS SDN. BHD. (Company No: 89708-V)

Ammended Copy

FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information

1.0 Submitter:

Perusahaan Getah Asas Sdn Bhd Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, Malaysia

Telephone No .:+603 3264 0787
Fax No .:+603 3264 0644

2.0 Contact Person:

Contact:Mr Kong Chang TAN
Telephone No.:+603 3291 1949
Fax No.:+603 3291 2903

3.0 Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim)

Common Name: Patient Examination Glove Classification Name: Patient Examination Glove

4.0 Identification of The Legally Marketed Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim), Class I patient examination gloves, Nitrile-80LZC, meets all of the requirements, of ASTM D 6319-00a83 Standard Specification for Nitrile Examination Gloves for Medical Application.

5.0 Description of Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83

1

Image /page/1/Picture/0 description: The image shows a logo with the letters "PGA" in white against a black background. The letters are bold and sans-serif. The background is a geometric shape, possibly a hexagon or octagon, with a textured or pixelated appearance. The overall design is simple and high-contrast.

PERUSAHAAN GETAH ASAS SDN. BHD.

(Company No: 89708-V)

Ammended Copy

6.0 Intended Use of the Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The glove may provide additional protection in other areas where users are handling certain hazardous chemicals such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

CharacteristicStandardsDevice Performance
DimensionsASTM D 6319-00aε,3Meets
Physical PropertiesASTM D 412-98Meets
Freedom from pin-holesASTM D 5151-99Meets
Powder Free ResidueASTM D 6124-01Meets
BiocompatibilityDermal Sensitization
(as per ASTM F-720-81)Not a contact skin sensitizer
Primary Skin Irritation Test
(as per 16 CFR Part 1500)Not a primary skin irritant
Cytotoxicity Test
(as per ISO 10993-5)Non cytotoxic
Low Dermatitis
PotentialModified Draize TestDid not induce clinically
significant skin irritation nor
show any evidence of
induced allergic contact
dermatitis in human subjects.

2

Image /page/2/Picture/0 description: The image shows a logo with the letters "PGA" in white, set against a dark background. The letters are stylized with a three-dimensional effect, giving them depth and prominence. The logo appears to be part of a larger image, with some dark areas visible in the periphery, suggesting it might be a cropped section of a poster or advertisement.

ERUSAHAAN GETAH ASAS SDN. BHD.

(Company No: 89708-V)

Ammended Copy

CharacteristicStandardsDevice Performance
Chemotherapy Drugs
Permeation TestASTM F 739Chemotherapy Drug Permeation
(average normalized breakthrough time in
minutes)
Carmustine (3.3 mg/mL) 137
Cisplatin (1.0 mg/mL) >240
Cyclophosphamide (20.0 mg/mL) >240
Dacarbazine (DTIC) (10.0 mg/mL) >240
Doxorubicin Hydrochloride (2.0 mg/mL) >240
5-Fluorouracil (50.0 mg/mL) >240
Etoposide (20.0 mg/mL) >240
Paclitaxel (Taxol) (6.0 mg/mL) >240
Thio-Tepa (10.0 mg/mL) >240

Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data

The performance test data that support a determination of substantial equivalence are described above.

Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data are not needed for examination gloves.

Conclusion 10.0

It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue It oan of contributed (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

labeling claims for the procession in ly equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. 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 image of an eagle with three wing-like shapes and two curved lines below, possibly representing waves or a stylized tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 € 2004

Mr. KK Leong Ouality Assurance/ Regulatory Affairs Manager Perusahaan Getah Asas Sdn. Bhd. Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, MALAYSIA

Re: K042805

Trade/Device Name: Powdered Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claims) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: December 2, 2004 Received: December 8, 2004

Dear Mr. Leong:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

4

Page 2 - Mr. Leong

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): K042805

Device Name: Powder Free Nitrile Patient Examination Gloves Colour Blue Non-Sterile (with Low dermation Potential and Chemotherapy Drugs Protection Labeling Claims)

Indications For Use: A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE `on another PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qute Mchcin O 12-15-04

Page 1 of /

(División Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K042805