(58 days)
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Not Found
No
The device description and performance data focus on the physical properties and barrier function of a standard medical glove, with no mention of AI or ML capabilities.
No.
The device description and intended use clearly state that it is a medical glove designed for barrier protection, not for treating any medical condition or disease.
No
The device is a medical glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a "Class 1 Nitrile Patient Examination Glove," which is a physical hardware device. The performance studies and key metrics also relate to the physical properties of the glove (watertightness, dimensions, thickness, tensile strength, etc.), not software performance.
Based on the provided information, 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 patients/their environment. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Class 1 Nitrile Patient Examination Glove." Gloves are typically considered medical devices for protection and barrier purposes, not for diagnosing conditions.
- Lack of Diagnostic Elements: The description and performance data focus on physical properties (length, width, thickness, strength, watertightness) and biocompatibility. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not perform such a 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80 LZA, 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
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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.
- Watertight (1000 ml): Pass GI AQL=4.0%
- Length (mm): Min 230 for all sizes (XS, S, M, L, XL), result 240 mm minimum for all sizes
- Palm width (mm):
- Size XS: result 75 - 78
- S: 80 +/- 10, result 82 - 88
- M: 95 +/- 10, result 92 - 98
- L: 111 +/- 10, result 102 - 108
- XL: result 111-115
- Thickness (mm) (Single Layer):
- Finger: Min 0.08, result 0.10 minimum
- Palm: Min 0.08, result 0.10 minimum
- Physical Properties Before Aging:
- Tensile Strength (Mpa): Min 14, result 16.5
- Ultimate Elongation (%): Min 500, result 550
- Physical Properties After Aging:
- Tensile Strength (Mpa): Min 14, result 23.1
- Ultimate Elongation (%): Min 500, result 520
- Powder Content: Below 2 mg / glove
The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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
NOV 17 1999
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 ~ 322 3200, Fax : 605 ~ 322 2300
| K993134 Attachment M | |
|---|---|
| SMDA 510 (K) SUMMARY | |
| 1.0 | |
| 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 4, 1999 |
| 3.0 Name of Device | |
| Trade Name | Cashmere Non-Sterile, Powder Free Nitrile |
| Examination Gloves (Blue) | |
| Cashmere Non-Sterile, Powder Free Nitrile | |
| Examination Gloves (Green) | |
| Common Name | Exam Glove |
| Classification Name | Nitrile Patient Examination Glove |
4.0 Identification of The Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80 LZA, 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 M
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 POWDER FREE NITRILE EXAM GLOVES |
|---|---|---|
| 1. Watertight (1000 ml) | GI | |
| 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 500 | 550 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| 6. Powder Content | - | Below 2 mg / glove |
Page 2 of 3
2
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 M
-
- The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
-
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue) and Gashmere Non-Sterile, Powder Free Nitrite Examination Gloves (Green) meet :
- = ASTM D3578-95 Standard
- FDA pinhole requirements
- ・ FDA minimum powder residual content
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
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 : K993134 Cashmere Non-Sterile Blue Powdered Nitrile Trade Name: Examination Gloves Requlatory Class: I Product Code: LZA Dated: October 23, 1999 Received: October 28, 1999
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 Requlations, Title 21, Parts 800 to 895. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
4
Page 2 - Mr. Hong
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 (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 ene regaracton cheroids, "NEWS andalig of "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,
Hy A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
K993134 510(K) Number :
: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue) Device Name Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Green)
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)
Prescription Use: ... ... ... ... ... ... .. .. . Per 21 CFR 80.109
OR
Over-The-Counter........\X........
Olim S. hin
(Division Sign-Off) Division of Dental, Infection Con and General Hospita F 1 (k) Number .