(44 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML technologies.
No
Explanation: A therapeutic device is used for the treatment or prevention of disease. This device, a medical glove, is primarily for preventing contamination, which is a barrier function rather than a direct therapeutic action on a patient's condition.
No
This device is a medical glove intended to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical medical glove, not a software application. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and patients/their environment. This is a barrier function, not a diagnostic function.
- Device Description: It describes a physical barrier (glove) meeting specific physical and performance standards (ASTM, FDA water leak test).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Metrics: The performance metrics listed are related to the physical integrity and properties of the glove (watertightness, dimensions, strength, powder/protein content), not diagnostic accuracy (sensitivity, specificity, etc., in a diagnostic context).
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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 patients' body, fluids, waste or environment.
Product codes
LYY
Device Description
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Watertight (1000 ml): Pass GI AQL=4.0%
Length (mm) Size XS: 240 mm minimum for all sizes
Length (mm) Size S: 240 mm minimum for all sizes
Length (mm) Size M: 240 mm minimum for all sizes
Length (mm) Size L: 240 mm minimum for all sizes
Length (mm) Size XL: 240 mm minimum for all sizes
Palm width (mm) Size XS: 75 - 78
Palm width (mm) Size S: 82 - 88
Palm width (mm) Size M: 92 - 98
Palm width (mm) Size L: 102 - 108
Palm width (mm) Size XL: 111 - 115
Thickness (mm) (Single Layer) Finger: 0.10 minimum
Thickness (mm) (Single Layer) Palm: 0.10 minimum
Physical Properties Before Aging Tensile Strength (Mpa): 16.5
Physical Properties Before Aging Ultimate Elongation (%): 550
Physical Properties After Aging Tensile Strength (Mpa): 23.1
Physical Properties After Aging Ultimate Elongation (%): 520
Powder Content: Below 2 mg / glove
Protein Content: Below 70 microgram / gram
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
Attachment L
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHD |
| Lot 72706, Jalan Lahat | ||
| Kawasan Perindustrian Bukit Merah | ||
| 31500 Lahat, Perak, Malaysia | ||
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Mr. CHAN CHIN HONG | |
| Date of Summary Prepared | September 20, 1999 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Non-Sterile, Polymer Coated Powder Free | |
| Latex Examination Gloves | ||
| Common Name | Exam Glove | |
| Classification Name | Polymer Coated Powder Free Patient Examination | |
| Glove |
4.0 Identification of The Legally Marketed Devices
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
1
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 -- 322 2300
Attachment L
7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-95 | CASHMERE POLYMER
COATED POWDER FREE
LATEX EXAM GLOVES |
|--------------------------------------------|-----------------|-------------------------------------------------------------|
| 1. Watertight (1000 ml) | G I
AQL=4.0% | Pass GI
AQL=4.0% |
| 2. Length (mm)
Size XS | Min 230 | 240 mm minimum for
all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)
Size XS | - | 75 - 78 |
| S | 80 +/- 10 | 82 - 88 |
| M | 95 +/- 10 | 92 - 98 |
| L | 111 +/- 10 | 102 - 108 |
| XL | - | 111 - 115 |
| 4. Thickness (mm)
(Single Layer) | | |
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties
Before Aging | | |
| Tensile Strength (Mpa) | Min 14 | 16.5 |
| Ultimate Elongation (%) | Min 700 | 550 |
| After Aging | | |
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - | Below 2 mg / glove |
| 7. Protein Content | - | Below 70 microgram / gram |
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Image /page/2/Picture/1 description: The image shows the 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1999
Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia
Re : K993326 Non-sterile Polymer Coated Powder Free Latex Trade Name: Examination Gloves with a Protein Labeling Claim (70 micrograms or less per gram) Requlatory Class: I Product Code: LYY Dated: September 29, 1999 October 4, 1999 Received:
Dear Mr. Hong:
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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Hong
the Federal Register. 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 findinq 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
Kga 3326 510(K) Number :
Prescription Use: ......................................
Per 21 CFR 80.109
: Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination, Device Name Cloves, Contains 70 microgram on less of Total rofa
Indication 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 patients' body, fluids, waste or environment.
| Concurrence of CDRH Office of Device Evaluation (ODC) | ||||||
|---|---|---|---|---|---|---|
..............................................................................................................................................................................
Chun S. Lin
OR
Over-The-Counter ... ... .................
(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
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