(34 days)
Not Found
No
The summary describes a standard examination glove and contains no mention of AI or ML technology.
No
The intended use statement indicates the device is for preventing contamination, not for therapeutic purposes.
No
Explanation: The device is described as a "patient examination glove," which is a barrier device used for protection, not for diagnosing medical conditions. The "Intended Use" clearly states its purpose is "to prevent contamination between patient and examiner."
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiners hand or finger".
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 "powder free patient examination glove... worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description confirms it's a "disposable device" and a "class I device having product code LYY." This classification and product code are consistent with medical gloves, not IVD devices.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a patient's health status
- Reagents, calibrators, or controls
Therefore, the information provided strongly indicates that this device is a medical glove used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Product codes
LYY
Device Description
Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand 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
The standards used by Koon Seng Sdn. Bhd. to determine substantial equivalence is based on ASTM D3578-05a. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5
Tests conducted include:
a. Dermal Sensitization Test: Passes
b. Primary Skin irritation: Passes
c. Iodine Test: Passes
d. Tensile strength: Gloves meets the requirements of ASTM D3578-05.
Key Metrics
Dermal Sensitization Test: Passes
Primary Skin irritation: Passes
Iodine Test: Passes
Tensile strength: Gloves meets the requirements of ASTM D3578-05.
AQL: 1.5%
Residual Powder Content: Max 2.0mg/glove
Residual Protein 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.
0
EXHIBIT #1
510(k) Summary
DEC - 2 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Applicant:
Koon Seng Sdn. Bhd. Ptd 16058. Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia
2. Manufacturer:
Koon Seng Sdn. Bhd. Ptd 16058, Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia
3. Submitter:
Mr. Jigar Shah Official Correspondent for Koon Seng Sdn. Bhd. Summary Prepared on: April 7, 2009
4. Address:
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 jigar@mdiconsultants.com
5. Trade/proprietary Name:
'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less).
6. Common Names: POWDER-FREE Patient Examination Glove
-
- Classification name: Patient Examination Glove
-
- Classification number: 21 CFR 880.6250
1
1
9. Device Description:
Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.
10. Intended Use:
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
11. Substantial Equivalence Discussion:
A powder free patient examination glove is substantially equivalent to the predicate devices.
| Characteristic
and
parameters | 'KS-CARE'
Powder Free
Polymer Coated
Latex
Examination
Glove with
Protein Content
labeling Claim
(50 Micrograms
or Less) | SGMP Company
Ltd. Powder-free
Latex
Examination
Gloves
510K # K071060 | Pt. Maja Agung
Latexindo
Powder-free
Latex
Examination
Gloves
510K # K081488 | Substantial
Equivalence
(SE) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LYY | LYY | LYY | |
| Intended Use | A powder free
patient
examination
glove is a
disposable device
intended for
medical purposes
that is worn on
the examiners
hand or finger to
prevent
contamination
between patient
and examiner. | A powder free
patient examination
glove is a
disposable device
intended for
medical purposes
that is worn on the
examiners hand or
finger to prevent
contamination
between patient and
examiner. | A powder free
patient
examination glove
is a disposable
device intended for
medical purposes
that is worn on the
examiners hand or
finger to prevent
contamination
between patient
and examiner. | SE |
| Width (size
medium) | 95 +/- 5 mm | 90-97mm | 95 +/- 5 mm | SE |
| Overall length | Min 240 mm | 241 mm | 240 mm | SE |
| Palm thickness | Min 0.08 mm | 0.10 mm | 0.10 mm | |
2
| Finger thickness | Min 0.08 mm | 0.13 mm | 0.10 mm | |
|---|---|---|---|---|
| Tensile strength pre aging min | Min 18 Mpa | 27 mpa | 18 mpa | |
| Tensile strength after aging min | Min 14 Mpa | 25.8 | 14 mpa | Minor difference |
| Ultimate elongation pre aging min | Min 650% | 830% | 650% | |
| Ultimate elongation after aging min | Min 500% | 730% | 500% | |
| Meets Biocompatibility | YES | Yes | Yes | SE |
| Duration of bio-compatibility | Except product change | |||
| Skin irritation test | Pass | Pass | Pass | SE |
| Dermal sensitization | Pass | Pass | Pass | |
| AQL | 1.5% | 2.5% | NA | SE |
| Residual Powder Content | Max 2.0mg/glove | 1.1 mg/glove | NA | SE |
| Residual Protein Level |