← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K202765
# ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765)
_Careplus (M) Sdn Bhd · KGO · May 27, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K202765
## Device Facts
- **Applicant:** Careplus (M) Sdn Bhd
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** May 27, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery
## Intended Use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
## Device Story
Sterile, powder-free latex surgical gloves; textured surface; manufactured via on-line polymer and anti-tack coating. Used by operating room personnel to protect surgical wounds from contamination. Tested for resistance to chemotherapy drug permeation per ASTM D6978. Provides barrier protection; reduces risk of wound contamination during surgical procedures.
## Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including ASTM D3577 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (residual powder), ASTM D6978 (chemotherapy permeation), and ISO 10993 (biocompatibility).
## Technological Characteristics
Natural rubber latex surgical gloves; powder-free with polymer/anti-tack coating. Titanium dioxide pigment. Sterilized via ISO 11137-2. Complies with ASTM D3577, D5151, D6124, D6978, D5712, and D7160. Protein content ≤ 50 µg/g.
## Regulatory Identification
A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
## Predicate Devices
- Encore Mark IV Powder Free Surgical Gloves ([K983489](/device/K983489.md))
## Submission Summary (Full Text)
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May 27, 2021
Careplus (M) SDN BHD Lim Shyan CEO/Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K202765
Trade/Device Name: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: April 13, 2021 Received: April 16, 2021
Dear Lim Shyan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K202765
#### Device Name
ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic
#### Indications for Use (Describe)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes |
|----------------------------------------|------------------------------------------------|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 13.2 |
| Thiotepa (10.0mg/ml) | 12.0 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >240 |
"WARNING: Do not use Carmustine and Thiotepa"
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# K202765
1.0
### 510(K) SUMMARY
- CAREPLUS (M) SDN BHD Applicant: Address: Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Phone No. 60-6-6772781 Fax No. 60-6-6772780 Contact Person Lim Kwee Shyan 2.0 Date of Summary 11th May, 2021 3.0 Device Information ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Device Name: Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic Common Name: Surgical Gloves Product Code: KGO Subsequent Product Code: LZC Classification Name: Surgeon's Gloves
### 4.0 Device Description
It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below:
Patient Examination Gloves Specialty (21 CFR 88.6250, LZC)
| Size | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 |
|--------------------|-----|-----|-----|-----|------|-----|-----|-----|
| Length, min. mm | 245 | 265 | | | | | | |
| Thickness, min. mm | | | | | 0.10 | | | |
| Width, ± 6 mm | 70 | 76 | 83 | 89 | 95 | 102 | 108 | 114 |
# 5.0 Predicate Device
K983489, Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), Ansell Perry. The device is a class I, Surgeon's Gloves, KGO, LZC powder-free..
#### 6.0 Indication for Use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect aa surgical wound from contamination.
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7.0 Technological Comparison Table:
| 7.0 Technological Comparison Table: | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | ASTM Specification | Standard References | Subject Glove K202765
(ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less and Tested for use with Chemotherapy drugs, Non-Pyrogenic) | Predicate Device (Encore Mark IV Powder Free Surgical Gloves, Protein Labeling Claim, K983489) | Discussion |
| Freedom from holes | ASTM D3577
ASTM D5151 | G-I, AQL 1.5 | Meets ASTM D3577
Meets ASTM D5151 | Meets ASTM D3577
Meets ASTM D5151 | Same |
| Dimension | ASTM D3577 | | | | Same |
| Length (size: 5.5), mm | | 245 min | min. 295 | Meet 245mm min | |
| Length (size: 6.0), mm | | 265 min | min. 295 | Meet 265mm min | |
| Length (size: 6.5), mm | | 265 min | min. 296 | Meet 265mm min | |
| Length (size: 7.0), mm | | 265 min | min. 295 | Meet 265mm min | |
| Length (size: 7.5), mm | | 265 min | min. 296 | Meet 265mm min | |
| Length (size: 8.0), mm | | 265 min | min. 296 | Meet 265mm min | |
| Length (size: 8.5), mm | | 265 min | min. 297 | Meet 265mm min | |
| Length (size: 9.0), mm | | 265 min | min. 295 | Meet 265mm min | |
| Thickness (cuff), mm | | 0.10 min | min. 0.158 | Meet 0.10mm min | |
| Thickness (palm), mm | | 0.10 min | min. 0.220 | Meet 0.10mm min | |
| Thickness (finger), mm | | 0.10 min | min. 0.225 | Meet 0.10mm min | |
| Width (size: 5.5), mm | | 70 ± 6 | 73-75 mm | Meet 70 ± 6 mm | |
| Width (size: 6.0), mm | | 76 ± 6 | 78-79 mm | Meet 76 ± 6 mm | |
| Width (size: 6.5), mm | | 83 ± 6 | 83-84 mm | Meet 83 ± 6 mm | |
| Width (size: 7.0), mm | | 89 ± 6 | 90-91 mm | Meet 89 ± 6 mm | |
| Width (size: 7.5), mm | | 95 ± 6 | 96-97 mm | Meet 95 ± 6 mm | |
| Width (size: 8.0), mm | | 102 ± 6 | 102-103 mm | Meet 102 ± 6 mm | |
| Width (size: 8.5), mm | | 108 ± 6 | 107-109 mm | Meet 108 ± 6 mm | |
| Width (size: 9.0), mm | | 114 ± 6 | 114-115 mm | Meet 114 ± 6 mm | |
| Physical Properties
(Before Ageing)
i) Tensile Strength (Mpa)
ii) Ultimate Elongation (%)
iii) Stress at 500% Elongation
(After Ageing)
i) Tensile Strength (Mpa)
ii) Ultimate Elongation (%) | ASTM D3577 | Min. 24
Min. 750
Max. 5.5
Min. 18
Min. 560 | min. 24
min. 780
max. 2.0
min. 20
min. 880 | Meets ASTM D3577 | Same |
| Powder Content | ASTM D3577
ASTM D6124 | Max. 2 mg/glove | Max. 0.57 mg/glove | Meets ASTM D3577
Meets ASTM D6124 | Same |
| K202765 | | | | | |
| Biocompatibility Test
i) Primary Skin Irritation
Test | ISO 10993-10 | No Animal
Irritation | Conclusion: Under the
conditions of this study,
the test material did not
cause and irritant
response. | Conclusion: Under the
conditions of this study,
the test material did not
cause and irritant
response. | Same |
| ii) Dermal Sensitization
Test | ISO 10993-10 | No Animal
Irritation | Conclusion: Under the
conditions of this study,
the test material did not
produce a skin
sensitization effect. | Conclusion: Under the
conditions of this study,
the test material did not
produce a skin
sensitization effect. | Same |
| iii) In vitro Cytotoxicity Test | ISO 10993-5 | | Conclusions: Under the
conditions of this study,
the test material is
cytotoxic (grade 4) at
undiluted, 1:2, 1:4, 1:8
dilutions; and
Non-cytotoxic, grade 2
at 1:16 dilution, grade 0
at 1:32 and 1:64
dilutions | iii) No data available | Different |
| iv) Acute Systemic Toxicity | ISO 10993-11 | | Conclusion: Under the
conditions of this study,
the test material both
inner and outer surface
did not reveal systemic
toxicity. | iv) No data available | Different |
| Protein Label Claim | | | Contains 50
micrograms or less of
total water extractable
protein per gram. | Contains 50
micrograms or less of
total water extractable
protein per gram. | Same |
| Chemo Drugs Claim | ASTM D6978 | - | Chemo Claim | No Chemo Claim | Different |
| Non- Pyrogenic Claim | ISO 10993-12 | - | Non-Pyrogenic | No Non-Pyrogenic
claim | Different |
| Color | | - | Natural | Natural | Same |
| White Pigment | | - | Titanium Dioxide | Titanium Dioxide | Same |
| Intended Use | | - | Powder Free Surgical
gloves are sterile
disposable devices
intended to be worn by
operating room
personnel to protect a
surgical wound from
contamination. | Powder Free Surgical
gloves are sterile
disposable devices
intended to be worn by
operating room
personnel to protect a
surgical wound from
contamination. | Same |
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| Chemotherapy Drug | ASTM D6978-05 | Subject Glove
(ENCORE® Latex Textured Surgical Gloves, Powder free with
Protein Content Labeling Claim (50 micrograms or less) and Tested
for use with Chemotherapy drugs, Non-Pyrogenic) |
|-------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Chemotherapy
Drug | Concentration | Minimum Breakthrough Detection Time (min) |
| Fluorouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 13.2 |
| *Thiotepa | 10.0mg/ml | 12.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
#### 8.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test that support a determination of substantial equivalence are the same as mentioned immediately above (ASTM requirement).
Following standards were used for the testing:
- ASTM D3577-09 Standard Specification for Rubber Surgical Gloves
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D5712-15 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
- ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
- ASTM D6978-16 Standard Assessment of Resistance of Medical Devices to Permeation
- ISO 11137-2:2013 Sterilization of Healthcare Products- Establishing the sterilization dose
#### 9.0 Summary of Clinical Testing
Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.
- 10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K202765](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K202765)
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