K Number
K030325
Device Name
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
Date Cleared
2003-03-28

(56 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves with Bubblegum Aroma
More Information

Not Found

Not Found

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

No
Explanation: The device is described as "Powder free Latex Examination Gloves with Bubblegum Aroma," intended to prevent contamination between a patient and an examiner. This falls under the category of protective barriers for examination and does not involve any therapeutic action or treatment for a disease or condition.

No
Explanation: The device is described as "Powder free Latex Examination Gloves with Bubblegum Aroma" and its intended use is "to prevent contamination between patient and examiner." This purpose is protective, not diagnostic.

No

The device is described as "Powder free Latex Examination Gloves with Bubblegum Aroma," which is a physical product worn on the hand, not a software application.

No, 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 purpose that is worn on examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used externally on the examiner's hand.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.

The device is a medical glove, which is a Class I medical device used for barrier protection, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
with 50 mcg/gm or less protein per glove

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

LYY

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

  • (7) Performance data is the same as mentioned immediately above.
  • (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
  • (9) Non-clinical data

We certify that our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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

Not Found

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

Image /page/0/Picture/0 description: The image is a black and white logo of SMC inside of a four leaf clover. The clover is inside of a circle. The letters SMC are in a sans-serif font and are stacked on top of each other.

PT. Shamrock nufacturine

Image /page/0/Picture/2 description: The image shows four different certification logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" underneath. The second logo is a stylized "GM" with text underneath. The third logo is a "TUV CERT" logo with the text "DIN EN ISO 9002 Certificate 0: 100 000071" underneath. The fourth logo is a "CE" mark.

MAR 2 8 2003

K030325

Page Numbers 1 of 2

K030325

"510 (K)" SUMMARY

| (1) Name of applicant
Address | : DR. SUPENO SURYA, MBA PhD
: PT. SHAMROCK Manufacturing Corp.
Jl. Pemuda No. 11
Medan 20151 - Indonesia
Phone No. : 62-61-455-8888
Fax No. : 62-61-452-0588 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person in U.S.A | : Emmy Tjoeng
Fax No. : 909-591-8878 |
| (2) Device details
Trade Name | : Powder free Latex Examination Gloves with Bubblegum Aroma |
| Classification Name | : Powder free Latex Examination Gloves with Bubblegum
Aroma |
| (3) Product Code | : 80 LYY |
| (4) Equivalent device legally
marketed | : Class I Examination Gloves 80 LYY
meeting ASTM D 3578-01ae2 |

OFFICE : Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 4520638 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com

FACTORY :

Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone (62-61) 703 0008 Fax. (62-61) 703 0007 E-mail : shamrock@indosat.net.id

1

Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with a four-leaf clover inside. The letters "SMC" are written in white across the clover. The clover is black, and the circle is outlined in black.

Image /page/1/Picture/2 description: The image shows four different certification logos. The first logo has a triangle with the text "TUV Rheinland Product Safety" underneath. The second logo has the letters "GM" in a stylized font. The third logo has the text "TUV CERT DIN EN ISO 9002 Certificate 01 153 000671". The fourth logo has the letters "CE".

500 % (min.)

Page Numbers 2 of 2

(5) Intended use : Powder free Latex Examination Gloves with bubblegum aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

(6) Technological characteristic of the gloves.

| a. Dimensions

SizesSmallMediumLargeX-Large
Length mm (min.)220230230230
Palm Width mm$80\pm10$$95\pm10$$110\pm10$$120 \pm10$
Thickness
1. Cuff mm (min)0.080.080.080.08
2. Palm mm(min)0.080.080.080.08
3. Finger Tip mm0.080.080.080.08
b. Physical PropertiesBefore ageingAfter ageing
at 70°C 168 hrs.
Tensile Strength: 18 Mpa (min)14 Mpa (min)

: 650 % (min.)

  • (7) Performance data is the same as mentioned immediately above.
  • (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
  • (9) Non-clinical data

Ultimate Elongation

We certify that our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

OFFICE :

Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 4520638 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com

FACTORY :

Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone (62-61) 703 0008 Fax. (62-61) 703 0007 E-mail : shamrock@indosat.net.id

2

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Official Correspondent For Shamrock Manufacturing Company, Incorporated 5445 Daniels Street Chino, California 91710

Re: K030325

Trade/Device Name: Powder Free Latex Examination Gloves with Bubblegum Aroma with 50 Micrograms or Less Protein Per Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 10, 2003 Received: January 31, 2003

Dear Ms. Tjoeng:

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.

3

Page 2 -- Ms. Tjoeng

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 (OS) 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 (301) 594-4618. 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.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Image /page/4/Picture/2 description: The image shows the logo for PT. Shamrock Manufacturing Corporation. The logo consists of a four-leaf clover with the letters SMC inside of it. To the right of the clover is the text "PT. Shamrock Manufacturing Corporation" in a bold, sans-serif font.

Image /page/4/Picture/3 description: The image shows four different certification logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" below it. The second logo is a black and white logo with the letters "GM" in it. The third logo is a "TUV CERT" logo with the text "DIN EN ISO 9002 Certificate 01 100 006971" below it. The fourth logo is a white logo with a black "C" in it.

ANNEXURE II

INDICATION FOR USE

Applicant Device Name Indication for use

: PT. SHAMROCK Manufacturing Corp.
: Powder free Latex Examination Gloves with Bubblegum Aroma
:
with 50 mcg/gm or less protein per glove

Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamigation between patient and examiner.

(signature)

DR.SUPENO SURYA, MBA PhD

(Type Name) 24. 03 MARCH (date)

Chin S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Dental Devic

510(k) Number:

OFFICE :

Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 4520638 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com

FACTORY : Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone (62-61) 703 0008 Fax. (62-61) 703 0007 E-mail : shamrock@indosat.net.id