(33 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and safety of a standard medical glove, with no mention of AI or ML technology.
No
The device is a medical glove intended for contamination prevention, not for treating or alleviating a disease or condition.
No
This device, a medical glove, is intended to prevent contamination between personnel and patients, not to diagnose any medical condition.
No
The device is a physical medical glove, not a software application. The description clearly outlines its material (latex) and physical properties, and the performance studies focus on physical characteristics like water tightness and biocompatibility. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a Class I latex patient examination glove. This is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the glove (water tightness, biocompatibility, powder content, protein level), which are relevant to its barrier function and safety, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / 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 patient.
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.
Product codes
LYY
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.
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
health care and similar personnel
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)
1. Dimension
Not applicable, detailed dimensions of the glove are provided and compared to ASTM D3578-95 standards.
2. Physical Properties
ASTM-D3578-95 Standard Specification for Latex Exam Gloves. Results for tensile strength and ultimate elongation before and after aging are provided and compared to ASTM standards.
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested. The results show the number of leaked gloves per batch and size, which are stated to be within the FDA/ASTM requirements of 4.0% AQL.
4. Biocompatibility
Tests performed: Primary Dermal Irritation Test, Skin Sensitization Study.
Results: Not a primary irritant, Not a sensitiser.
The test results show that the gloves meet FDA biocompatibility requirements.
5. Total Residual Powder Content & Presence of Cornstarch
Tests performed: Residual Powder Content per ASTM D 6124-97, Presence of Cornstarch.
Results: Residual powder content range 1.5-1.9 mg/glove, mean 1.7 mg/glove (max 2 mg/glove allowed). Presence of Cornstarch: Negative.
These figures are within the FDA Internal Requirement.
6. Residual Protein Level
Test performed: ASTM D 5712-95.
Results: Claimed level
§ 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.
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APPENDIX H
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM 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 GREEN 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 YY, 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 | ||
| Small | ||
| Medium | ||
| Large | 70 mm +/- 10 mm | |
| 80 mm +/- 10mm | ||
| 95 mm +/- 10mm | ||
| 111mm +/- 10mm | 70 - 75 mm | |
| 80 - 85 mm | ||
| 90 - 97 mm | ||
| 105 - 111 mm | ||
| Length | 230 mm minimum | |
| for all sizes | 242mm | |
| Thickness - | ||
| Finger | ||
| Palm | 0.08mm min | |
| 0.08mm min | 0.08 mm min | |
| 0.08 mm min |
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The characters are 'K991743'. The characters are written in black ink on a white background. The handwriting is somewhat stylized.
| 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 | ||||
| 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
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
2
991743
| TESTS | FDA INTERNAL
REQUIREMENT | SHIELD's |
|--------------------------------------------------|-----------------------------|-----------------------------------------------|
| Residual Powder
Content per
ASTM D 6124-97 | 2 mg/glove max | Range: 1.5-1.9mg/glove
Mean : 1.7 mg/glove |
| Presence of Cornstarch | Negative | Negative |
5. Total Residual Powder Content & Presence of Cornstarch
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | Sincer ely Timo |
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.
510K Number:
Device Name: Royal Shield Powder Free Latex Examination Gloves With Bubble gum seent thotein content labeling claim (50 microgram or 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)
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Prescription Use ... ... Per 21 CFR 801.109
OR
Over-The-Counter........X
Chien S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number