(35 days)
Not Found
Not Found
No
The device is a medical glove and the description and performance data relate to physical properties and biocompatibility, with no mention of AI or ML.
No
The device is a medical glove intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is described as a medical glove intended to prevent contamination between healthcare personnel and patients. Its described use and performance metrics relate to its barrier function and physical properties, not to diagnosing any medical condition.
No
The device is a physical medical glove made of nitrile, 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' bodies and fluids. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the material (nitrile), class (Class 1), and standards it meets (ASTM D6319-00, FDA Water Leak Test). These are all related to the physical properties and barrier function of the glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity and biocompatibility of the glove, not on its ability to diagnose a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A medical glove 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D6319-00 and FDA 1000 ml watertight test.
Key results are tabulated:
- Watertight (1000 ml): Pass GI AQL=2.5%
- Length (mm): 240 mm minimum for all sizes
- Palm width (mm):
XS: 110 - Thickness (mm) (Single Layer):
Finger: 0.10 minimum
Palm: 0.10 minimum - Physical Properties:
Before Aging:
Tensile Strength (Mpa): 15.2
Ultimate Elongation (%): 670
After Aging:
Tensile Strength (Mpa): 19.7
Ultimate Elongation (%): 760 - Powder Content: Below 2mg / glove
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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.
0
APR 2 2 2002
K 020868
SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
| 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 | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | 14th January 2002 | |
| 3.0 | Name of Device | |
| Trade Name | Cashmere Non-Sterile, Powder Free Nitrile | |
| Examination Gloves (White) | ||
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
4.0 Identification of the Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A medical glove 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.
Page 1 of 3 ATTACHMENT L
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
7. Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00 and FDA 1000 ml watertight test.
| TEST | ASTM D6319-00 | CASHMERE POWDER
FREE NITRILE EXAM
GLOVES |
|-------------------------------------|----------------|------------------------------------------------|
| 1. Watertight (1000 ml) | GI
AQL=2.5% | Pass GI
AQL=2.5% |
| 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 | - | 110 |
| 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 14.0 | 15.2 |
| Ultimate Elongation (%) | Min 500 | 670 |
| After Aging | | |
| Tensile Strength (Mpa) | Min 14.0 | 19.7 |
| Ultimate Elongation (%) | Min 400 | 760 |
| 6. Powder Content | - | Below 2mg / glove |
Page 2 of 3 ATTACHMENT L
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
-
- The performance data of the glove as showed above meet the ASTM D6319-00 Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
-
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
10. Conclusion
We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves meet:
- -ASTM D6319-00 Standard
- FDA pinhole requirements -
- FDA minimum powder residual content ・
Page 3 of 3 ATTACHMENT L
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2002
Mr. Chun Chooi Fong Quality Assurance Department Manager Seal Polymer Industries Sdn. Bhd. LT 72706. Jalan Lahat, Kawasan Perindustrian Bukit Merah Lahat, Ipoh, Perak, MALAYSIA 31500
Re: K020868
Trade/Device Name: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: March 13, 2002 Received: March 18, 2002
Dear Mr. Fong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothý Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
Ko20868 510(K) Number :
Device Name : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White)
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, -.
.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)
Prescription Use: ... ... ... ... ... ...... Per 21 CFR 80.109
OR
Over-The-Counter ... ... ... ... .......
Qian S. Lin
(Division Sign-Off) (Division of Dental, Infection Control, Division ral Hospital Devices 510(k) Number --