ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

K991746 · Shield Gloves Manufacturer (M) Sdn Bhd · LYY · Jun 23, 1999 · General Hospital

Device Facts

• Record ID: K991746
• Device Name: ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
• Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Royal Shield powder-free latex examination gloves; designed for use by healthcare personnel to prevent cross-contamination. Device features pineapple scent and protein content labeling (<50 µg/g). Manufactured using standard latex dipping processes with added scenting step and optional light chlorination; titanium dioxide used in formulation. Gloves provide physical barrier protection; performance verified against ASTM D3578-95 standards for dimensions, tensile strength, and elongation. Biocompatibility confirmed via primary dermal irritation and skin sensitization studies. Device is non-sterile and intended for over-the-counter use.

Clinical Evidence

Bench testing only. Includes ASTM D3578-95 physical property testing (tensile strength, elongation), ASTM D6124-97 residual powder content, ASTM D5712-95 residual protein levels, and FDA 1,000 ml water leak test. Biocompatibility supported by primary dermal irritation and Buehler skin sensitization studies.

Technological Characteristics

Latex examination glove; powder-free. Materials: Latex, titanium dioxide, pineapple flavor (258212). Dimensions: 242mm length; 0.08mm min thickness. Standards: ASTM D3578-95 (physical properties), ASTM D6124-97 (powder), ASTM D5712-95 (protein). Protein level <50 µg/g. Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier 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

• K953496

Submission Summary (Full Text)

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# APPENDIX H

### 510(k) SUMMARY

# SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH PINEAPPLE SCENT AND PROTEIN CONTENT LABELING

### Contact person : Ong Lay Mau

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### Device Information:

Trade Name - ROYAL SHIELD POWDER FREE LATEX EXAM GLOVES Common Name - Exam gloves Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80L Y Y , powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

#### Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

#### Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device:

#### 1. Dimension

| DIMENSION | ASTM D3578-95 | ROYAL SHIELD |
|-------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------|
| X-Small<br>Small<br>Medium<br>Large | 70 mm +/- 10 mm<br>80 mm +/- 10mm<br>95 mm +/- 10mm<br>111mm +/- 10mm | 70 - 75 mm<br>80 - 85 mm<br>90 - 97 mm<br>105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

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| | | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------|---------------|------------------|---------------|---------------------|--|
| | ASTM-D3578-95 | SHIELD's | ASTM-D3578-95 | SHIELD's | |
| Before Aging | 14.0 Mpa min | 21.0 Mpa | 700 % | 800% | |
| After Aging<br>22 hrs @100C | 14.0 Mpa min | 16.0 Mpa | 500% | 750% | |

- 2. Physical Properties (ASTM-D3578-95 Standard Specification for Latex Exam Gloves)
# 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested and our results are as given below:

| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|------------|---------|-------------|-------------|------------------|
| 9903031019 | X-Small | 200 | Yes | 2 |
| 9903222024 | Small | 200 | Yes | 2 |
| 9904011027 | Medium | 200 | Yes | 1 |
| 9903162023 | Large | 200 | Yes | 4 |

The above figures are within the FDA/ ASTM requirements for latex exam gloves of 4.0% AQL.

# 4. Biocompatibility

The test results below show that the gloves meet FDA biocompatibility requirements:

BIOCOMPATIBILITY TESTS

Primary Dermal Irritation Test

Skin Sensitization Study

RESULTS

Not a primary irritant

Not a sensitiser

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# 5. Total Residual Powder Content & Presence of Cornstarch

.

| TESTS | FDA INTERNAL<br>REQUIREMENT | SHIELD's |
|--------------------------------------------------|-----------------------------|-----------------------------------------------|
| Residual Powder<br>Content per<br>ASTM D 6124-97 | 2 mg/glove max | Range: 1.5-1.9mg/glove<br>Mean : 1.7 mg/glove |
| Presence of Cornstarch | Negative | Negative |

## 6. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|---------------------------------------|
| ASTM D 5712-95 | < 50 µg/g | < 50 µg/g<br>Range: 27-33<br>Mean: 30 |

### Conclusion :-

The data presented indicate that the Royal Shield Powder Free latex examination glove with Pineapple scent

- 1. meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove,
- 2. meets FDA pinhole requirements,
- 3. meets SHIELD's labeling claim of its being a powder free glove.
- 4. meets the protein labeling claim level at <50 µg/g

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#### DUSTING OR DONNING POWDER 12.0

Contents for items 9.0 to 12.0 are similar to those contained in our previous submission and granted a 510(k) # K 953496 attached as APPENDIX C.

#### 13.0 'POWDER-FREE GLOVES'

APPENDIX D-1 shows the Process Flow Chart, with the addition of a scenting step. There is also an optional step of lightly chlorinating the gloves during the washing stage as devicted in APPENDIX D-2, as well as a slight change of the polymer coating materials to the ones given as per APPENDICES D-3 AND D-4. All the rest of the process is as per previous submission.

## 15.0 WATER SOLUBLE PROTEIN LEVEL OF GLOVES WITH A PROTEIN LABELING CLAIM:

As per 510(k) # K953496 except that the sampling frequency is now at once a week per machine. APPENDIX E-1 show the consistency of the protein level while APPENDIX E-2 shows that scenting the glove does not change the protein content of the resultant glove at all.

# 17.0 COLOR or FLAVOR ADDITIVE

No color additive is used except for the titanium dioxide used in the basic formulation.

The Pineapple scent used is 258212 Pineapple Flavor, nature-identical, artificial.

Please refer to :-

APPENDIX -F Product Specification & MSDS

#### 18.0 GLOVE BIOCOMPATIBILITY

We enclose the bio-compatibility data as per APPENDIX-G .

- (a) Primary Dermal Irritation Test Study # T99-0008-2
Result : Negative Conclusion : Glove is considered not a primary dermal irritant.

(b) Skin Sensitization Study (BUEHLER) Study - Study # T99-0008-2 by CPTC

Result : negative Conclusion : Glove is considered not a sensitiser.

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#### Shelf Life Expiration Data: 19.0

For this particular version of gloves, there is as yet insufficient data to indicate an expiration date for the gloves.

#### SMDA 510 (K) REQUIREMENT 21.0

:

APPENDIX-H gives a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

b

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Image /page/5/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a bowl. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Shield Gloves Manufacturer (M) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 21114 Crofton, MD

Re : K991746

> Trade Name: Royal Shield™ Powder Free Pineapple Scented Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: May 10, 1999 Received: May 21, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੀ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action.

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Page 2 - Mr. Smith

In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. Ulatowski Timo ny Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd,

510K Number:

Device Name: Royal Shield Powder Fre on ICREGIONS a ontent Labelma with Indications For Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ... ... Per 21 CFR 801.109

OR

Over-The-Counter...X

Qhin Si him

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number