CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA

• K Number: K050532
• Device Name: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA
• Manufacturer: SPI GLOVES SDN. BHD.
• Date Cleared: 2005-04-14 ( 43 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a patient examination glove, and the summary focuses on its physical properties and compliance with standards, with no mention of AI or ML.

Therapeutic

No.
This device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.

Diagnostic

No

Explanation: The intended use of the device is described as preventing contamination between patient and examiner, which is a barrier function, not a diagnostic one. There is no mention of the device being used to identify or detect a disease, condition, or other health anomaly.

SaMD (Software as a Medical Device)

No

The device description and performance data clearly indicate a physical medical device (a patient examination glove) and do not mention any software component.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or other conditions.
• Device Description: The description is of a "Class 1 Latex Patient Examination Glove," focusing on physical properties and adherence to standards like ASTM D3578-01a52 and FDA Water Leak Test.
• Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing diagnostic information
  • Using reagents or assays

The performance data provided relates to the physical integrity and safety of the glove (watertightness, dimensions, thickness, tensile strength, biocompatibility), which are relevant for a medical device used as a barrier, but not for an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

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

LYY

Device Description

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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)

Performance data of gloves based on ASTM D3578-01a52 and FDA 1000 ml watertight test.
Key results are tabulated:

• Watertight (1000 ml): Pass G1, AQL=2.5%
• Length (mm): 240 mm minimum for all sizes
• Palm width (mm): 110 mm (XL)
• Thickness (mm) (Single Layer) - Finger: 0.10 minimum
• Thickness (mm) (Single Layer) - Palm: 0.10 minimum
• Physical Properties - Before Aging - Tensile Strength (Mpa): 19.9
• Physical Properties - Before Aging - Ultimate Elongation (%): 835
• Physical Properties - After Aging - Tensile Strength (Mpa): 16.5
• Physical Properties - After Aging - Ultimate Elongation (%): 786
• Powder Content: Below 2mg / glove
• Protein Content: Below 50 microgram / gram
  The performance data meet the ASTM D3578-01a52 Standard and FDA's requirement. Powder content is below 2mg per glove, which meets the FDA Requirements.
  Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.

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

• AQL=2.5% for watertight test.
• Powder content is below 2mg per glove.
• Protein content is below 50 microgram / gram.

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

Regulation Number and Section

§ 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.

Summary

0

APR 1 4 2005

K050532

SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 3045() Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

1.0	SMDA 510 (K) SUMMARY
2.0	Submitter	SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8,
Greentown Business Centre,
30450 Ipoh, Perak, Malaysia.
	Tel	(60 5) 322 3200
	Fax	(60 5) 322 2300
	Name of Contact Person	Ms. CHUN CHOOI FONG
	Date of Summary Prepared	February 7, 2005
3.0	Name of Device
	Device Name	Chlorinated Powder Free Latex Examination Gloves
	Common Name	Exam Glove
	Classification Name	Latex Patient Examination Glove

Identification of the Legally Marketed Devices 4.0

Class 1 Latex Patient Examination Glove 80LYY, powder free that mects all the Class - Datex Patting Standard D3578-01a22 and FDA requirements.

5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The Intended Use of Glove 6.0

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

1

SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. c-mail: [e-mail]

7. Summary of Performance Data:

Performance data of gloves based on ASTM D3578-01a52 and FDA 1000 ml watertight test.

| TEST | ASTM D3578-01a2 | CHLORINATED POWDER FREE
LATEX EXAM GLOVES |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------|
| 1. Watertight (1000 ml) | G 1
AQL=2.5% | Pass Gl
AQL=2.5% |
| 2. Length (mm)
Size XS
S
M
L
XL | Min 230
Min 230
Min 230
Min 230
Min 230 | 240 mm minimum for
all sizes |
| 3. Palm width (mm)
Size XS
S
M
L
XL | -
80 +/- 10
95 +/- 10
111 +/- 10

•  | 110 mm |
  

| 4. Thickness (mm)
(Single Layer)
Finger
Palm | Min 0.08
Min 0.08 | 0.10 minimum
0.10 minimum |
| 5. Physical Properties
Before Aging
Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14.0
Min 650 | *19.9
*835 |
| After Aging
Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14.0
Min 500 | *16.5
*786 |
| 6. Powder Content | - | Below 2mg / glove |
| 7. Protein Content | - | Below 50 microgram / gram |

• The average results obtain from Attachment C.

2

SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

• The performance data of the glove as showed above meet the ASTM D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
• The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
• 10. Conclusion

We concluded that the Chlorinated Powder Free Latex Examination Gloves meet the below specifications:

• ASTM D3578-01a52 Standard -
• FDA pinhole requirements -
• FDA minimum powder residual content -

Page 3 of 3 ATTACHMENT N

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.

Public Health Service

APR 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5. Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA

Re: K050532

Trade/Device Name: Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005

Dear Ms. Chooi Fong:

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 Eederal Register.

4

Page 2 - Ms. Chooi Fong

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chia-Lin, 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 STATEMENT

: SPI Gloves Sdn. Bhd. Applicant

510(K) Number: K050532

Device Name : Chlorinated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 micrograms or less of Total Water Extractable Protein per Gram)

Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)

Prescription Use: 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file: PHP Test php phpinfo(); ? OR Over-The-Counter X Per 21 CFR 80.109 Anesth May 5 Hogy, General Hospital, Con Control. Denial Devices Number K050532

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