(35 days)
Not Found
Not Found
No
The device is a standard patient examination glove and the summary focuses on material properties and performance against established standards, with no mention of AI or ML.
No
The device, a patient examination glove, is intended for prevention of contamination, not for treatment or therapy.
No
The device is described as a "patient examination glove," which is a barrier device for contamination prevention, not for diagnosing conditions.
No
The device description clearly states it is a "Class 1 Latex Patient Examination Glove," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and infection control during patient examination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This glove does not perform any such test.
- Device Description: The description focuses on the physical properties and performance of the glove as a barrier, not on any diagnostic function.
- Lack of IVD-related information: There is no mention of analyzing samples, detecting analytes, or any other activity typically associated with IVD devices.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
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 D3578-01 and FDA 1000 ml watertight test.
Key results:
- Watertight (1000 ml): Pass GI AQL=4.0%
- Length (mm): 240 mm minimum for all sizes (XS, S, M, L, XL)
- Palm width (mm):
XS: 75 - 78
S: 82 - 88
M: 92 - 98
L: 102 - 108
XL: 111 - 115 - Thickness (mm) (Single Layer):
Finger: 0.10 minimum
Palm: 0.10 minimum - Physical Properties:
Before Aging:
Tensile Strength (Mpa): 18.7* (Min 14)
Ultimate Elongation (%): 956* (Min 650)
After Aging:
Tensile Strength (Mpa): 18.3* (Min 14)
Ultimate Elongation (%): 938* (Min 500)
(* The average result taken from Attachment B2.) - Powder Content: Below 2 mg / glove
- Protein Content: Below 50 microgram / gram
The performance data of the glove as showed above meet the ASTM D3578-01 Standard and FDA's requirement. Powder content is below 2 mg per glove that meets the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
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
SEP 2 6 2002
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia.
Tel: 605-3223 200 Fax: 605- 3222 300
E-mail: spoly@po.jaring.my
| 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 | August 8, 2002 |
| 3.0 | Name of Device | |
|---|---|---|
| Trade Name | Cashmere Powder Free Latex Examination Gloves E protein labeling claim |
Exam Glove
Patient Examination Glove
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the
Identification of The Legally Marketed Devices
requirements of ASTM Standard D3578-01 and FDA requirements.
Common Name
4.0
Classification Name
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.
The Intended Use of Glove 6.0
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Page 1 of 3 ATTACHMENT M
1
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my
7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-01 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01 | CASHMERE POWDER FREE LATEX 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 | 18.7* |
| Ultimate Elongation (%) | Min 650 | 956* |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 18.3* |
| Ultimate Elongation (%) | Min 500 | 938* |
| 6. Powder Content | - | Below 2 mg / glove |
| 7. Protein Content | - | Below 50 microgram / gram |
· The average result taken from Attachment B2.
Page 2 of 3 ATTACHMENT M
2
SEAL POLYMER INDUSTRIES SDN. BHD.
Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my
-
- The performance data of the glove as showed above meet the ASTM D3578-01 Standard and FDA's requirement. Powder content is below 2 mg per glove that meets the FDA Requirements.
-
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Cashmere Powder Free Latex Examination Gloves meet:
- -ASTM D3578-01 Standard
- FDA pinhole requirements -
- -FDA minimum powder residual content
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2002
Mr. Chun Chooi Fong Quality Assurance Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrain Bukit Merah, 31500 Lahat, Perak, MALAYSIA
Re: K022792
Trade/Device Name: Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Coated Online Chlorinated) Contains 50 Micrograms or Less Of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYY Dated: August 13, 2002 Received: August 22, 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
Page 2 - Mr. Fong
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 (OS) 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
K022792 510(K) Number :
: Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Device Name Coated Online Chlorinated) Contains 50 mcgin or less et Tefal Coated Online Chiomatod) Cerritoris per grain
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)
Prescription Use: ... ... ... ... ... ............ Per 21 CFR 80.109
OR
Over-The-Counter .......................
St. Paul's tiv Ulin
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KC12792
Page 5